Combined Arm Stretch Positioning and Neuromuscular Electrical Stimulation in Patients After Stroke A Random Trial

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de Jong et al: Combined arm positioning and NMES poststroke

Combined arm stretch positioning and neuromuscular


electrical stimulation during rehabilitation does not
improve range of motion, shoulder pain or function in
patients after stroke: a randomised trial
Lex D de Jong1,2, Pieter U Dijkstra2,3, Johan Gerritsen4, Alexander CH Geurts5 and
Klaas Postema2
1
School of Physiotherapy, Hanze University of Applied Sciences, Groningen, 2Department of Rehabilitation Medicine, University of Groningen,
University Medical Center Groningen, Groningen, 3Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center
Groningen, 4ViaReva, Center for Rehabilitation, Apeldoorn, 5Department of Rehabilitation, Radboud University Nijmegen Medical Center, Nijmegen
The Netherlands

Question: Does static stretch positioning combined with simultaneous neuromuscular electrical stimulation (NMES) in
the subacute phase after stroke have beneficial effects on basic arm body functions and activities? Design: Multicentre
randomised trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Participants: Forty-six
people in the subacute phase after stroke with severe arm motor deficits (initial Fugl-Meyer Assessment arm score )
18). Intervention: In addition to conventional stroke rehabilitation, participants in the experimental group received arm
stretch positioning combined with motor amplitude NMES for two 45-minute sessions a day, five days a week, for eight
weeks. Control participants received sham arm positioning (ie, no stretch) and sham NMES (ie, transcutaneous electrical
nerve stimulation with no motor effect) to the forearm only, at a similar frequency and duration. Outcome measures:
The primary outcome measures were passive range of arm motion and the presence of pain in the hemiplegic shoulder.
Secondary outcome measures were severity of shoulder pain, restrictions in performance of activities of daily living,
hypertonia, spasticity, motor control and shoulder subluxation. Outcomes were assessed at baseline, mid-treatment, at
the end of the treatment period (8 weeks) and at follow-up (20 weeks). Results: Multilevel regression analysis showed no
significant group effects nor significant time × group interactions on any of the passive range of arm motions. The relative
risk of shoulder pain in the experimental group was non-significant at 1.44 (95% CI 0.80 to 2.62). Conclusion: In people
with poor arm motor control in the subacute phase after stroke, static stretch positioning combined with simultaneous
NMES has no statistically significant effects on range of motion, shoulder pain, basic arm function, or activities of daily
living. 5SJBMSFHJTUSBUJPO: NTR1748. <EF+POH-% %JKLTUSB16 (FSSJUTFO+ (FVSUT"$) 1PTUFNB, 
$PNCJOFEBSN
stretch positioning and neuromuscular electrical stimulation during rehabilitation does not improve range of motion,
TIPVMEFSQBJOPSGVODUJPOJOQBUJFOUTBGUFSTUSPLFBSBOEPNJTFEUSJBMJournal of Physiotherapyo>

Keywords: Stroke, Upper extremity, Muscle stretching exercises, Electrical stimulation, Activities of daily
living, Randomized controlled trial

Introduction (Coupar et al 2010) or constraint-induced movement therapy


(Sirtori et al 2009). However, these interventions are not
Annually, 15 million people worldwide suffer a stroke suitable for people with severe motor deficits because they
(Mackay and Mensah 2004). About 77–81% of stroke require ‘active’ residual arm motor capacity. For these
survivors show a motor deficit of the extremities (Barker people ‘passive’ interventions may be needed to prevent
and Mullooly 1997). In almost 66% of patients with an secondary impairments and optimise long-term handling
initial paralysis, the affected arm remains inactive and
immobilised due to a lack of return of motor function after
six months (Sunderland et al 1989, Wade et al 1983). Over What is already known on this topic: Contracture of
time, the central nervous system as well as muscle tissue muscles in the arm after stroke is common. Stretch
of the arm adapt to this state of inactivity, often resulting alone does not typically produce clinically important
in residual impairments such as hypertonia (de Jong et al reductions in contracture in people with neurological
2011, van Kuijk et al 2007), spasticity (O’Dwyer et al 1996) conditions. Hypertonia may limit the application of
or contractures (Kwah et al 2012, O’Dwyer et al 1996, stretch and therefore its potential benefits.
Pandyan et al 2003). In turn, these secondary impairments What this study adds: In people with poor arm
are associated with hemiplegic shoulder pain (Aras et al motor control after stroke, static arm positioning to
2004, Roosink et al 2011) and restrictions in performance stretch muscles prone to contracture combined with
neuromuscular stimulation of the antagonist muscles
of activities of daily living (Lindgren et al 2007, Lundström did not have significant benefits with respect to range
et al 2008). of motion, shoulder pain, performance of activities of
daily living, hypertonia, spasticity, motor control or
Several interventions improve arm function after stroke and shoulder subluxation.
prevent secondary impairments, eg, bilateral arm training

Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013 245


Research

and assistive use of the affected arm. It is also important Method


to elicit muscle activity if at all possible, and to improve
arm function. To prevent the loss of passive range of joint Design
motion as a result of contracture of at-risk muscles in the A multicentre, assessor-blinded, randomised controlled
shoulder (eg, internal rotators, adductors) and forearm trial was conducted. After inclusion, participants were
(eg, pronators, wrist and finger flexors) in particular, the randomised in blocks of four (2:2 allocation ratio) in two
application of arm stretch positioning alongside regular strata (Fugl-Meyer Assessment arm score 0–11 points
physiotherapy was deemed important (Ada and Canning and 12–18 points) at each treatment centre. Opaque,
1990), especially because contractures are associated with sealed envelopes containing details of group allocation
shoulder pain (Aras et al 2004, de Jong et al 2007, Wanklyn were prepared by the main co-ordinator (LDdJ) before
et al 1996). However, in general, passive stretch does not trial commencement. After a local trial co-ordinator had
produce clinically important changes in joint range of determined eligibility and obtained a patient’s consent, the
motion, pain, spasticity, or activity limitations (Katalinic et main co-ordinator was contacted by phone. He instructed an
al 2011). One explanation for the lack of effect of passive independent person to draw an envelope blindfolded and to
stretch of the shoulder muscles could be the inadequate communicate the result back to the local trial co-ordinator.
duration of stretch, with clinical trials using a dose of 20 or The local trial co-ordinator then made arrangements
30 minutes only (Borisova and Bohannon 2009). However, for the baseline measurement after which the allocated
it is questionable whether stretch of the shoulder muscles intervention was initiated. Mid-treatment, end-treatment,
for much more than 60 minutes per day during intensive and follow-up measurements took place at 4, 8, and 20
rehabilitation programs is feasible (Turton and Britton weeks after baseline measurement by two independent
2005). assessors (physiotherapists), who were unaware of group
allocation and not involved in the treatment of participants.
People with severe motor deficits after stroke have a To keep the assessors blinded, participants were reminded
higher risk of developing increased resistance to passive before each measurement not to reveal the nature of their
muscle stretch (hypertonia) and spasticity of the muscles treatment. Participants were considered to be unaware of
responsible for an antigravity posture (de Jong et al 2011, group allocation because they were informed about the
Kwah et al 2012, Urban et al 2010). These muscles are also existence of two intervention groups but not about the
at risk of developing contracture. As a result, the passive study hypothesis. The participants’ and assessors’ beliefs
range of the hemiplegic shoulder (exteral rotation, flexion regarding allocation were checked at the eight-week (ie, end
and abduction), elbow (extension), forearm (supination) and of treatment) assessment using a three-point nominal scale
wrist (extension) can become restricted. (I suspect allocation to experimental/control group, I have
Stretching hypertonic muscles is difficult when they are no clue of group allocation). All investigators, staff, and
not sufficiently relaxed. Cyclic neuromuscular electrical participants were kept blinded with regard to the outcome
stimulation (NMES) (Chae et al 2008), another example of measurements.
a ‘passive’ intervention, can not only be used to improve Participants
pain-free range of passive humeral lateral rotation (Price
and Pandyan 2000), but also to reduce muscle resistance Between August 2008 and September 2010, consecutive
(King 1996) and glenohumeral subluxation (Pomeroy et newly admitted patients on the neurological units of three
al 2006, Price and Pandyan 2000). From these results we rehabilitation centres in the Netherlands (Beetsterzwaag,
hypothesised that NMES of selected arm muscles opposite Doorn, and Zwolle) were approached for participation.
to muscles that are prone to the development of spasticity Willing patients were initially screened by a physician for
and contracture might facilitate static arm stretching both the following inclusion criteria: first-ever or recurrent stroke
through reciprocal inhibition (‘relaxation’) of antagonist (except subarachnoid haemorrhages) between two and eight
muscles (Alfieri 1982, Dewald et al 1996, Fujiwara et al weeks poststroke; age > 18 years; paralysis or severe paresis
2009) and the imposed (cyclic) stretch caused by motor of the affected arm scoring 1–3 on the recovery stages
amplitude NMES. Consequently, static arm stretch of Brunnstrom (1970); and no planned date of discharge
positioning combined with NMES could potentially result within four weeks. Subsequently, a local trial co-ordinator
in larger improvements of arm passive range of motion and excluded patients with: contraindications for electrical
less (severe) shoulder pain compared to NMES or static stimulation (eg, metal implants, cardiac pacemaker); pre-
stretching alone. From these hypotheses we developed the existing impairments of the affected arm (pre-existing
following research questions: contracture was not an exclusion criterion); severe cognitive
1. Does eight weeks of combined static arm stretch deficits and/or severe language comprehension difficulties,
positioning with simultaneous NMES prevent the loss defined as < 3/4 correct verbal responses and/or < 3 correct
of shoulder passive range of motion and the occurrence visual graphic rating scale scores on the AbilityQ (Turner-
of shoulder pain more than sham stretch positioning Stokes and Rusconi 2003); and moderate to good arm
with simultaneous sham NMES (ie, transcutaneous motor control (> 18 points on the Fugl-Meyer Assessment
electrical stimulation, TENS) in the subacute phase arm score).
of stroke?
2. Does the experimental intervention have any additional Interventions
effects on timing and severity of shoulder pain, All participants received multidisciplinary stroke
restrictions in daily basic arm activities, resistance to rehabilitation, ie, daily training in activities of daily
passive stretch (hypertonia) and spasticity, arm motor living by rehabilitation nurses, occupational therapists,
control, and the degree of shoulder subluxation? physiotherapists, and speech therapists. These interventions
were not standardised, but generally administered in a
way that was consistent with the recommendations of

246 Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013


de Jong et al: Combined arm positioning and NMES poststroke

A B C

Figure 1. Experimental and control arm muscle stretch positions and electrode placements. (a) The intervention used by
experimental group participants with sufficient shoulder external rotation to achieve the position. (b) The intervention used
by experimental group participants with insufficient shoulder external rotation. (c) The control (ie, sham) intervention.

the Dutch stroke guidelines (Van Peppen et al 2004). the same two trained assessors. Every effort was made to
Participants were requested to undergo the additional motivate participants to undergo all planned measurements
allocated treatment twice daily for 45 minutes on weekdays even after withdrawal from the study.
for 8 weeks. Participants from the experimental group
received arm stretch positioning (presented in Figures 1a Passive range of shoulder external rotation, flexion and
and 1b) with simultaneous four-channel motor amplitude abduction, elbow extension, forearm supination, wrist
NMES. Participants from the control group received a extension with extended and flexed fingers were assessed
sham stretch positioning procedure (presented in Figure because these movements often develop restrictions in range
1c) with simultaneous sham conventional TENS with as a result of imposed immobility, with muscle contractures
minimal sensory sensation by using a similar treatment causing a typical flexion posture of the hemiplegic arm. The
protocol, electrical stimulator and electrode placement (entire) ShoulderQ was administered in participants who
(but on the forearm only) as the experimental group. A indicated that they had shoulder pain. This questionnaire
detailed description of the experimental and control group assesses timing and severity of pain by means of eight
procedures can be found in Appendix 1 (see the eAddenda verbal questions and three vertical visual graphic rating
for Appendix 1). scales. We were primarily interested in the answer to the
(verbal) question How severe is your shoulder pain overall?
Treatment was planned to result in 60 hours of positioning (1= mild, 2 = moderate, 3 = severe, 4 = extremely severe)
and 51 hours of NMES/TENS. All procedures were and pain severity measured at rest, on movement, and at
performed by the local trial coordinator or instructed night using the 10-cm vertical visual graphic rating scales.
nursing staff. Nursing staff monitored compliance to the The ShoulderQ is sensitive (Turner-Stokes and Jackson
intervention by logging each session on a record sheet, 2006) and responsive to change in pain experience (Turner-
which was always kept in the vicinity of the participant’s Stokes and Rusconi 2003). Performance of basic functional
bed. During the first 8 weeks of the trial, prescription of activities of daily life involving the passive arm was
pain and spasticity medication as well as content of physical assessed using the Leeds Adult/Arm Spasticity Impact Scale
and occupational therapy sessions for the arm were also (Ashford et al 2008). Using this semi-structured interview,
monitored. participants were asked to indicate whether they or their
carer(s) experienced difficulty performing 12 different
Outcome measures tasks involving the hemiplegic arm (cleaning the palm/
The primary outcome measures were passive range of arm elbow/armpits, cutting fingernails, putting the arm through
motion and pain in the hemiplegic shoulder. All goniometric a sleeve/in a glove, rolling over in bed, doing exercises,
assessments were performed by two observers using a balancing while standing/walking, and holding objects).
fluid-filled goniometera. Inter-observer reliability of this The scores on the separate items (1 point = no difficulty,
technique was high (de Jong et al 2012). The presence of 0 = difficulty or activity not yet performed) were summed,
shoulder pain was checked using the first (yes/no) question divided by the total number of items performed and
of the ShoulderQ (Turner-Stokes and Jackson 2006). The multiplied by 100, resulting in a summary score (0 = severe
secondary outcome measures were timing and severity of disability, 100 = no disability). Hypertonia and spasticity of
poststroke shoulder pain, performance of real-life passive the shoulder internal rotators, elbow flexors, and long finger
and basic daily active arm activities, hypertonia and flexors were assessed using a detailed version (Morris
spasticity, arm motor control and shoulder subluxation. All 2002) of the Tardieu Scale (Held and Pierrot-Deseilligny
measurements were carried out in the same fixed order by 1969). The Tardieu Scale can differentiate spasticity from

Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013 247


Research

Screened for eligibility (n = 260)

Excluded after initial screening (n = 180)a Excluded after inclusion testing (n = 32)
t OPJTDIBFNJDIBFNPSSIBHJDTUSPLF O
t unable to fill out, read or understand the AbilityQ (n = 9)
t > 8 weeks post stroke (n = 28) t Fugl-Meyer Assessment Arm score > 18 points (n = 14)
t Brunnstrom’s recovery stage * 4 (n = 169) t contraindications to electrical stimulation (n = 1)
t pre-existing arm impairments (n = 24) t other reasons (n = 8)
t planned date of discharge too soon (n = 64)
t SFGVTFEVOBCMFUPQBSUJDJQBUF O

t other (n = 8)b
t VOLOPXONJTTJOHEBUB O


Measured passive range of motion, shoulder pain, restrictions in performance of activities


PGEBJMZMJGF IZQFSUPOJBTQBTUJDJUZ NPUPSDPOUSPMBOETIPVMEFSTVCMVYBUJPO
Week 0
(n = 24) Randomised (n = 24)
(n = 23) Analysedc (n = 23)

Experimental group Control group


Discontinued Lost to follow-up
t multidisciplinary stroke t multidisciplinary stroke
intervention treadmission to
rehabilitation rehabilitation
tshoulder hospitald (n = 1)
t static arm positioning t sham arm positioning
pain (n = 2) Discontinued
and NMES 90 min per and TENS 90 min per
intervention
day, 5 days per week day, 5 days per week
tdischarge (n = 1)

Measured passive range of motion, shoulder pain, restrictions in performance of activities


Week 4 PGEBJMZMJGF IZQFSUPOJBTQBTUJDJUZ NPUPSDPOUSPMBOETIPVMEFSTVCMVYBUJPO
(n = 21) Received prescribed intervention (n = 21)
(n = 23) Analysed (n = 21)e

Experimental group Control group


Lost to follow-up Discontinued
t multidisciplinary stroke t multidisciplinary stroke
tdeath (n = 1) intervention
rehabilitation rehabilitation
tincreased tforearm pain (n = 1)
t static arm positioning t sham arm positioning
shoulder pain and NMES 90 min per and TENS 90 min per trecurrent stroke
(n = 1) day, 5 days per week day, 5 days per week (n = 2)
Discontinued tdischarge (n = 1)
intervention
tdischarge (n = 1)

Measured passive range of motion, shoulder pain, restrictions in performance of activities


Week 8 PGEBJMZMJGF IZQFSUPOJBTQBTUJDJUZ NPUPSDPOUSPMBOETIPVMEFSTVCMVYBUJPO
(n = 18) Received prescribed intervention (n = 17)
(n = 21) Analysed (n = 21)f

Experimental group Control group


Lost to follow-up
t no intervention t no intervention
tsevere shoulder
subluxation (n = 1)
tdid not attend
(n = 3)

Measured passive range of motion, shoulder pain, restrictions in performance of activities of


Week 20 EBJMZMJGF IZQFSUPOJBTQBTUJDJUZ NPUPSDPOUSPMBOETIPVMEFSTVCMVYBUJPO
(n = 17) Analysed (n = 22)

Figure 2. Design and flow of participants through the trial. a All reasons for exclusion are listed where patients were ineligible
for multiple reasons. bIncluding multiple sclerosis, Alzheimer’s disease, locked-in syndrome, recurrent stroke, and
participation in another trial. NMES = neuromuscular electrical stimulation. cOne participant from each group dropped out
after randomisation but before receiving any intervention. dUnrelated to stroke. eOne participant missed the Week 4
assessment due to poor weather. fOne participant missed the Week 8 assessment due to recurrent stroke but was
subsequently available for the Week 20 follow-up assessment.

248 Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013


de Jong et al: Combined arm positioning and NMES poststroke

5BCMF Baseline characteristics of participants and datasets, we aimed to recruit at least 20 participants per
centres. group.
Characteristic Exp Con All participants minus two premature dropouts were
(n = 23) (n = 23) analysed as randomised (intention-to-treat). Arm passive
Age (yr), mean (SD) 56.6 (14.2) 58.4 (9.6) range of motion was analysed using a multilevel regression
Time post-stroke at 43.7 (13.3) 43.3 (15.5) analysis. As main factors time (baseline, 4, 8, and 20 weeks),
baseline (days), group allocation (2 groups) and time × group interaction
mean (SD) were explored using the –2log-likelihood criterion for
MMSEa, median 27 (23 to 28.25) 28 (26 to 29.5) model fit, as well as random effects of intercept and slope.
(IQR) For completeness, this analysis was repeated using the data
Gender, n males 15 (65) 12 (52) of the participants including the two premature dropouts (n
(%) = 48) using the last observation carried forward approach.
Stroke type, n (%) Nominal outcome measures (presence of hypertonia/
ICVA 19 (83) 18 (78) spasticity and subluxation) at eight weeks were analysed
HCVA 4 (17) 5 (22) using a Chi-square test. Ordinal outcome measures (Fugl-
Meyer Assessment, Leeds Adult/Arm Spasticity Impact
Affected 12 (52) 8 (35)
hemisphere, n right
Scale, ShoulderQ) were first analysed for time effects
(%) within subjects using the Friedman test. If differences over
Aphasia, n (%) 5 (22) 6 (26)
time (from baseline to follow-up) were found, these were
further explored using the Wilcoxon signed-rank test with
Initial FMA arm
Bonferroni-Hochberg correction (Norman and Streiner
score, n (%)
2000). Between-group differences were analysed using
0–11 points 19 (83) 17 (74)
a Mann-Whitney U test only at 8 weeks to avoid multiple
12–18 points 4 (17) 6 (26) testing.
Centres,
participants Results
treated, n (%)
Beetsterzwaag 7 (30) 8 (35) Flow of participants through the trial
Doorn 4 (17) 4 (17) The flow of participants through the trial is presented in
Zwolle 12 (52) 11 (48) Figure 2. Forty-eight patients met all eligibility criteria.
Exp = experimental group, Con = control group, FMA = One participant from the experimental group (a 68-year-
Fugl-Meyer Assessment arm score, HCVA = haemorrhagic old female with a right-sided ischaemic stroke who
cerebrovascular accident, ICVA = ischaemic cerebrovascular regretted participation) and one from the control group (a
accident, MMSE = Mini Mental State Examination. aNot
administered in subjects with aphasia.
62-year old male with a left-sided ischaemic stroke who
was rehospitalised due to acute liver and kidney failure)
dropped out the day after baseline measurement and before
receiving any intervention. These participants were not
contracture (Haugh et al 2006, Patrick and Ada 2006) and included in the analyses because their data were missing
has fair to excellent test-retest reliability and inter-observer due to unavailability for further measurements.
reliability (Paulis et al 2011). The mean angular velocity
of the Tardieu Scale’s fast movement was standardised Of the 11 patients who were lost to follow-up or
(see the eAddenda for Appendix 2). Muscle reaction discontinued their prescribed intervention during the
quality scores * 2 were considered to be clinically relevant 8-week treatment period, four (36%) complained of pain.
hypertonia. Spasticity was deemed present if the angle of Baseline characteristics of the 46 participants analysed are
catch was present and occurred earlier in range than the shown in Table 1. Twenty-two participants (51%, n = 43)
maximal muscle length after slow stretching (ie, spasticity had no clue as to which group they were allocated, but 17
angle > 0 degs). Arm motor control was assessed using the participants (40%) were correct in their belief regarding
66-point arm section of the Fugl-Meyer Assessment (Fugl- allocation. The three participants who were lost to follow-
Meyer et al 1975, Gladstone et al 2002). Shoulder inferior up before 8 weeks did not provide data about allocation
subluxation was diagnosed by palpation (Bohannon and beliefs. The two assessors had no clue regarding group
Andrews 1990) in finger breadths (< ½, < 1, * 1, > 1½) and allocation in 67% and 72% of the cases. They were correct
considered present if it was one category higher than on the in their belief regarding allocation in 9 (21%) and 4 (9%) of
nonaffected side. the participants, respectively.

Data analysis Co-interventions and compliance with trial


method
Sample size calculation was based on a reliably assessable
change in passive shoulder external rotation range of In the experimental group more participants were prescribed
motion of * 17 degs (de Jong et al 2012). The clinically pain and spasticity medication, as presented in Table 2.
relevant difference between the experimental and control They also received slightly more conventional therapy for
intervention was therefore set at a minimum of 20 deg. The the arm and adhered less to the prescribed intervention
standard deviation was considered to be 21.5 deg (Ada et al protocol. Overall, compliance in the experimental group
2005). Alpha was set at 5% (two-sided), beta at 80%. Thus, was 68% (stretch positioning) and 67% (NMES), compared
the required number of participants in each group was 18. to 78% (sham positioning) and 75% (TENS) in the control
Anticipating a 10% drop-out rate and requiring 36 complete group. Non-compliance was mainly caused by drop-out and

Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013 249


Research

5BCMF. Mean (SD) or number of participants (%) for co-interventions and compliance to the intervention protocol during
the eight-week intervention period and mean difference (MD) or percentage risk difference (RD) between groups, with
95% confidence intervals (95% CI).

Outcome Groups Difference between groups (95% CI)


Exp Con
(n = 23) (n = 23)
Prescription of pain medication, n (%) 16 (73)a 11 (48) RD 25% (–4% to 50%)
Prescription of spasticity medication, n (%) 5 (23)a 2 (9) RD 14% (–8% to 36%)
Upper limb occupational therapy (hr), mean (SD) 5 (4)a 4 (4)a MD 1 (–2 to 3)
Upper limb physiotherapy (hr), mean (SD) 3 (5) 2 (3)a MD 1 (–2 to 3)
Total of positioning (hr), mean (SD) 41 (17)a 47 (16) MD –6 (–15 to 4)
Total of electrical stimulation (hr), mean (SD) 34 (16)a 38 (14) MD –4 (–13 to 5)
Exp = experimental group, Con = control group. aData missing for one participant.

early weekend leaves. All mentioned differences between Discussion


the groups were not statistically significant.
To our knowledge this is the first study to analyse the effects
Effect of intervention of a daily arm stretch positioning procedure combined with
All primary and secondary outcome measures are simultaneous NMES in patients with a poor prognosis for
presented in Tables 3, 4 and 5. Individual participant data functional recovery in the subacute phase after stroke.
are presented in Table 6 (see eAddenda for Tables 4, 5 and The 8-week high-intensity multimodal intervention did
6). Except for elbow extension and the control participants’ not result in any significant differences in arm passive
wrist extension with extended fingers, both groups showed range of motion (contractures), shoulder pain, basic arm
reductions in mean passive range of motion of all joints activities, hypertonia/spasticity, arm motor control or
(Table 3). The multilevel regression analysis identified shoulder subluxation compared to a control group receiving
significant time effects for the three shoulder movements a similar amount of sham positioning combined with TENS
and for forearm supination. There was no significant group in addition to conventional rehabilitation.
effect nor a significant time × group interaction. A random Previous attempts to maintain hemiplegic arm joint range
intercept model fitted the data best (–2log-likelihood of motion using static muscle stretching procedures could
criterion). At end-treatment, the mean between-group not prevent considerable loss of shoulder passive range of
difference for passive shoulder external rotation was 13 deg motion (Ada et al 2005, Gustafsson and McKenna 2006, de
(95% CI 1 to 24). Jong et al 2006, Turton and Britton 2005). Our participants
At baseline, 37% of all participants (ie, 17/46) reported showed similar reductions in mean passive range of motion
shoulder pain, as presented in Table 4 (see eAddenda for across most arm joints. Overall, there were no significant
Table 4). At 8 weeks, this percentage was 52% (ie, 22/42) differences in passive range of motion between the two
with a relative risk of shoulder pain in the experimental groups. At baseline (on average, six weeks post-stroke),
group of 1.44 (95% CI 0.80 to 2.62), but no significant 37% of the participants reported (shoulder) pain. During
difference between the groups (r2 = 1.53, p = 0.217). At the intervention period, the prevalence increased to 52%
follow-up 36% (ie, 13/39) of all participants had shoulder and decreased to 36% three months later. These findings
pain. At 8 weeks, participants with shoulder pain showed are in line with reports that post-stroke shoulder pain is
no significant between-group differences in their responses common, affecting 22–64% of cases, particularly patients
to the verbal question as well as in the visual graphic with poor arm function (Aras et al 2004, Gamble et al 2002,
rating scale scores on movement and at night. Overall, the Lindgren et al 2007). Overall, pain severity also increased,
pain scores showed inconsistent patterns which hindered particularly on movement and at night. This adverse effect
within- and between-group comparisons of those with was also noted in other trials (Gustafsson and McKenna
shoulder pain only. There were no significant between- 2006, Turton and Britton 2005). Although there were no
group differences on the Leeds Adult/Arm Spasticity significant between-group differences regarding shoulder
Impact Scale, the Modified Tardieu Scale, the Fugl-Meyer pain, worrisome observations were that in the experimental
Assessment arm score, and the subluxation scores at end- group some participants reported that they considered
treatment, as presented in Table 5 (see eAddenda for Table the intervention to be very arduous, pain and spasticity
5). It is of note that all participants with clinically relevant medication were prescribed more frequently, and protocol
hypertonia also demonstrated a spasticity angle > 0 deg and compliance was lower. Combined with the finding that
that Tardieu Scale scores for the internal rotators could not shoulder pain was more likely to occur in participants in the
be obtained in a large number of participants because they experimental group than in the control group (relative risk
had very limited (< 70 deg) total shoulder external rotation 1.44), these findings may indicate that for some participants
range. The overall prevalence of subluxation decreased the experimental procedure was not well tolerated.
from baseline (61%) to follow-up (31%). During the eight weeks of intervention our participants
showed increased Leeds Adult/Arm Spasticity Impact
Scale sum scores and Fugl-Meyer Assessment arm motor
scores – changes that were probably not clinically relevant

250 Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013


Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013

5BCMF. Mean (SD) for passive range of motion in degrees for each group, mean (SD) difference within groups, and mean (95% CI) difference between groups. The multi-level
regression analysis identified significant time effects for the three shoulder movements and for forearm supination. There was no significant group effect nor a significant group
x time interaction. A random intercept results in the best fit for the data (–2log-likelihood criterion).

Outcome Groups Difference within groups Difference between groups

Week 0 Week 4 Week 8 Week 20 Week 4 Week 8 Week 20 Week 4 Week 8 Week 20
minus minus minus minus minus minus
Week 0 Week 0 Week 0 Week 0 Week 0 Week 0

Exp Con Exp Con Exp Con Exp Con Exp Con Exp Con Exp Con Exp minus Exp minus Exp
(n = 23) (n = 23) (n = 23) (n = 21) (n = 21) (n = 21) (n = 17) (n = 22) Con Con minus
Con
Shoulder 29 34 20 19 18 11 20 21 –9 –14 –10 –23 –5 –13 5 13 8
external (20) (19) (28) (21) (23) (24) (29) (25) (17) (14) (15) (21) (23) (21) (–5 to 14) (1 to 24) (–7 to 22)
rotation
Shoulder 130 122 111 104 107 100 107 103 –18 –15 –22 –22 –16 –18 –3 0 2
flexion (33) (29) (37) (22) (37) (20) (36) (20) (24) (18) (26) (30) (31) (27) (–16 to 10) (–17 to 18) (–17 to 21)

Shoulder 110 93 93 71 92 66 84 72 –17 –17 –18 –27 –18 –20 0 9 2


abduction (48) (41) (51) (32) (51) (27) (46) (27) (41) (21) (48) (34) (49) (33) (–20 to 20) (–17 to 35) (–24 to 29)

Elbow 3 3 2 5 3 5 6 2 –1 1 0 2 2 –1 –2 –2 3
extensiona (8) (7) (9) (7) (10) (7) (12) (12) (6) (5) (8) (7) (8) (11) (–5 to 2) (–7 to 3) (–4 to 9)

de Jong et al: Combined arm positioning and NMES poststroke


Forearm 77 78 68 68 67 69 59 67 –8 –9 –10 –9 –15 –12 1 –1 –3
supination (13) (11) (16) (15) (17) (12) (16) (16) (12) (17) (12) (12) (18) (14) (–8 to 10) (–8 to 7) (–13 to 7)
Wrist 58 54 55 47 56 54b 54 59 –3 –5 –2 0b –2 6 2 –3 –8
extension I (18) (17) (20) (14) (20) (16) (20) (14) (11) (12) (15) (16) (20) (19) (–5 to 9) (–12 to 7) (–21 to 5)

Wrist 66 60 59b 53 62 57 60 63 –6 –6 –4 –3 –4 3 0 –1 –7
extension II (12) (14) (17) (13) (18) (15) (20) (15) (9) (8) (11) (14) (16) (15) (–5 to 5) (–9 to 6) (–17 to 4)
Exp = experimental group, Con = control group, I = wrist extension with extended fingers, II = wrist extension with flexed fingers. aElbow extension values indicate deviation from the neutral
position, ie, degrees of elbow flexor contracture with negative values representing hyperextension. bData missing for one participant.
251
Research

and caused by a mix of spontaneous post-stroke recovery of intervention will not have a clinically relevant impact in this
function, learned capacity to use compensatory movement subgroup of patients either.
strategies of the nonaffected arm and/or increased
involvement of the carer. Overall, the prevalence of elbow Research to date suggests that it is not possible to control or
flexor hypertonia and spasticity jointly increased up to 55% overcome (the emergence of) contractures and hypertonia
at the end of the treatment period, roughly corresponding to using the current static arm muscle stretching procedures.
three months post-stroke for our participants. These results Similarly, NMES of the antagonists of the muscles prone
are in concordance with previous work (de Jong et al 2011, to shortening does not seem to provide additional benefits
van Kuijk et al 2007, Urban et al 2010). The unexpected either. We therefore argue that these techniques should
high prevalence of hypertonia and spasticity (62%) and be discontinued in the treatment of patients with a poor
a decreasing prevalence of shoulder subluxation (31%) prognosis for functional recovery. In this subgroup of
at follow-up in our sample may be explained by the fact patients it is becoming an increasingly difficult challenge to
that patients with relatively poor arm motor control have a find effective treatments that can prevent the development
higher risk of developing hypertonia (de Jong et al 2011). of the most common residual impairments such as
contractures, hypertonia, and spasticity and its associated
Although we performed an intention-to-treat analysis (ie, secondary problems such as shoulder pain and restrictions
using any available data from all randomised subjects), we in performance of daily life activities. Further research is
did not use forward imputation of missing data representing required to investigate what renders these interventions
a clinical variable (eg, shoulder passive range of motion) ineffective. The efficacy of other approaches, such as
that is worsening over time (de Jong et al 2007), as this transcranial magnetic stimulation, NMES of the muscles
might increase the chance of a Type I error. However, for prone to shortening (Goldspink et al 1991), or other
completeness, this stricter intention-to-treat analysis using combinations of techniques, could also be investigated. Q
the data of all randomised subjects (n = 48) was performed.
This analysis was similar in outcome to the original analysis
but revealed an additional time effect of wrist extension
with flexed fingers. A per protocol analysis would also have Footnotes: aMIE Medical Research Ltd, Leeds, UK.
b
resulted in similar results because no patients crossed over STIWELL-med4, Otto Bock HealthCare, Germany.
to the other group. We also refrained from performing a eAddenda: Table 4, 5, 6 (individual patient data) and
sensitivity analysis based on compliance because meaningful Appendix 1 and 2.
conclusions could not be drawn from the resulting limited
sample sizes. We furthermore acknowledge that the Leeds Ethics: The study was approved by the Medical Ethics
Adult/Arm Spasticity Impact Scale lacks psychometric Committee of the University Medical Center Groningen.
evaluation and our method to standardise the Tardieu All participants gave written informed consent prior to
Scale’s stretch velocity (V3) using a metronome was not participation.
validated and tested for reliability. Therefore, our data
regarding basic arm activities, hypertonia, and spasticity Support: This study was financially supported by Fonds
should be interpreted with caution. Finally, because NutsOhra [SNO-T-0702-72] and Stichting Beatrixoord
overall compliance to both protocols was only about 70%, Noord-Nederland.
an underestimation of the treatment effect may also have
occurred. Nevertheless, the combined administration of 43 Acknowledgements: We thank the assessors Ank Mollema
hours of static stretching and 36 hours of NMES was more and Marian Stegink (De Vogellanden, Zwolle), the local
than administered during any previous trial (Borisova and trial co-ordinators Marijke Wiersma and Siepie Zonderland
Bohannon 2009). (Revalidatie Friesland, Beetsterzwaag), Astrid Kokkeler
and Dorien Nijenhuis (MRC Aardenburg, Doorn), Alinda
A recent study produced inconclusive evidence about Gjaltema and Femke Dekker (De Vogellanden, Zwolle)
the effectiveness of a combined intervention of electrical and the participants, physicians, physio- and occupational
stimulation in conjunction with prolonged muscle stretch therapists and nursing staff involved in the trial.
(using a splint) to treat and prevent wrist contracture
(Leung et al 2012). Similarly, our results also showed Competing interests: Otto Bock Healthcare provided
no added benefit of electrical stimulation during static electrical stimulators free of charge. None of the sponsors
stretching of the shoulder and arm. The results of these had any involvement in study design, data collection
multimodal approaches to the problem of post-stroke arm and analysis, decision to publish, or preparation of the
contracture development are in line with the conclusion of manuscript.
a review (Katalinic et al 2011) that static stretch positioning
procedures have little, if any, short or long term effects Correspondence: Lex D de Jong, Hanze University of
on muscle contracture (treatment effect ) 3 deg), pain, Applied Sciences, School of Physiotherapy, Eyssoniusplein
spasticity, or activity limitations. Although pooled data from 18, 9714 CE Groningen, The Netherlands. Email: l.d.de.
studies investigating the effects of electrical stimulation [email protected]
suggested some treatment effects on functional motor
ability (Pomeroy et al 2006) and pain-free range of passive References
humeral lateral rotation in patients with residual arm motor Ada L, Canning C (1990) Anticipating and avoiding muscle
capacity (Price and Pandyan 2000), we found no such shortening. In Ada L, Canning C (Eds) Key Issues in
results in our sample of patients without residual arm motor /FVSPMPHJDBM 1IZTJPUIFSBQZ 0YGPSE #VUUFSXPSUI
capacity. As the combined procedure did not result in any Heinemann, pp 219–236.
meaningful treatment effects, it suggests that application Ada L, Goddard E, McCully J, Stavrinos T, Bampton J (2005)
of muscle stretching or NMES alone as a monotherapeutic Thirty minutes of positioning reduces the development

252 Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013


de Jong et al: Combined arm positioning and NMES poststroke

of shoulder external rotation contracture after stroke: a Gladstone DJ, Danells CJ, Black SE (2002) The Fugl-Meyer
randomized controlled trial. Archives of Physical Medicine assessment of motor recovery after stroke: a critical review
& Rehabilitation 86: 230–234. of its measurement properties. Neurorehabilitation & Neural
Repair 16: 232–240.
Alfieri V (1982) Electrical treatment of spasticity. Reflex
tonic activity in hemiplegic patients and selected specific Goldspink DF, Easton J, Winterburn SK, Williams PE,
electrostimulation. Scandinavian Journal of Rehabilitation Goldspink GE (1991) The role of passive stretch and
Medicine 14: 177–182. repetitive electrical stimulation in preventing skeletal muscle
atrophy while reprogramming gene expression to improve
Aras MD, Gokkaya NK, Comert D, Kaya A, Cakci A (2004)
fatigue resistance. Journal of Cardiac Surgery 6: 218–224.
Shoulder pain in hemiplegia: results from a national
rehabilitation hospital in Turkey. American Journal of Gustafsson L, McKenna K (2006) A programme of static
Physical Medicine & Rehabilitation 83: 713–719. positional stretches does not reduce hemiplegic shoulder
Ashford S, Slade M, Malaprade F, Turner-Stokes L (2008) pain or maintain shoulder range of motion – a randomized
Evaluation of functional outcome measures for the controlled trial. Clinical Rehabilitation 20: 277–286.
hemiparetic upper limb: a systematic review. Journal of Haugh AB, Pandyan AD, Johnson GR (2006) A systematic
Rehabilitation Medicine 40: 787–795. review of the Tardieu Scale for the measurement of
Barker WH, Mullooly JP (1997) Stroke in a defined elderly spasticity. Disability & Rehabilitation 28: 899–907.
population, 1967–1985. A less lethal and disabling but no Held J, Pierrot-Deseilligny E (1969) Le bilan moteur central. In
less common disease. Stroke 28: 284–290. Rééducation motrice des affections neurologiques. Paris:
Bohannon RW, Andrews AW (1990) Shoulder subluxation and Libraire Balliere, pp 31–42.
pain in stroke patients. American Journal of Occupational Katalinic OM, Harvey LA, Herbert RD (2011) Effectiveness of
Therapy 44: 507–509. stretch for the treatment and prevention of contractures in
Borisova Y, Bohannon RW (2009) Positioning to prevent or people with neurological conditions: a systematic review.
reduce shoulder range of motion impairments after stroke: Physical Therapy 91: 11–24.
a meta-analysis. Clinical Rehabilitation 23: 681–686. King TI, II (1996) The effect of neuromuscular electrical
Brunnstrom S (1970) Movement therapy in hemiplegia: a stimulation in reducing tone. American Journal of
neurophysiological approach. Hagerstown: Harper and Occupational Therapy 50: 62–64.
Row. Kwah LK, Harvey LA, Diong JH, Herbert RD (2012) Half of the
Chae J, Sheffler L, Knutson J (2008) Neuromuscular electrical adults who present to hospital with stroke develop at least
stimulation for motor restoration in hemiplegia. Topics in one contracture within six months: an observational study.
Stroke Rehabilitation 15: 412–426. Journal of Physiotherapy 58: 41–47.

Coupar F, Pollock A, van Wijck F, Morris J, Langhorne P (2010) Leung J, Harvey LA, Moseley AM, Tse C, Bryant J, Wyndham
Simultaneous bilateral training for improving arm function S, et al (2012) Electrical stimulation and splinting were not
after stroke. Cochrane Database of Systematic Reviews clearly more effective than splinting alone for contracture
CD006432. management after acquired brain injury: a randomised trial.
Journal of Physiotherapy 58: 231–240.
de Jong LD, Dijkstra PU, Stewart RE, Postema K (2012)
Repeated measurements of arm joint passive range of Lindgren I, Jonsson AC, Norrving B, Lindgren A (2007)
motion after stroke: interobserver reliability and sources of Shoulder pain after stroke: a prospective population-based
variation. Physical Therapy 92: 1027–1035. study. Stroke 38: 343–348.

de Jong LD, Hoonhorst MH, Stuive I, Dijkstra PU (2011) Arm Lundström E, Terent A, Borg J (2008) Prevalence of disabling
motor control as predictor for hypertonia after stroke: a spasticity 1 year after first-ever stroke. European Journal of
prospective cohort study. Archives of Physical Medicine & Neurology 15: 533–539.
Rehabilitation 92: 1411–1417. Mackay J, Mensah G (2004) The atlas of heart disease and
de Jong LD, Nieuwboer A, Aufdemkampe G (2006) Contracture stroke. Geneva: World Health Organization.
preventive positioning of the hemiplegic arm in subacute Morris S (2002) Ashworth and Tardieu Scales: their clinical
stroke patients: a pilot randomized controlled trial. Clinical relevance for measuring spasticity in adult and paediatric
Rehabilitation 20: 656–667. and neurological populations. Physical Therapy Reviews 7:
de Jong LD, Nieuwboer A, Aufdemkampe G (2007) The 53–62.
hemiplegic arm: interrater reliability and concurrent validity Norman G, Streiner D (2000) Biostatistics: the bare essentials.
of passive range of motion measurements. Disability & Toronto: Dekker Inc.
Rehabilitation 29: 1442–1448.
O’Dwyer NJ, Ada L, Neilson PD (1996) Spasticity and muscle
Dewald JP, Given JD, Rymer WZ (1996) Long-lasting reductions contracture following stroke. Brain 119: 1737–1749.
of spasticity induced by skin electrical stimulation. IEEE
Pandyan AD, Cameron M, Powell J, Stott DJ, Granat MH
Transactions on Rehabilitation Engineering 4: 231–242.
(2003) Contractures in the post-stroke wrist: a pilot study
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S of its time course of development and its association with
(1975) The post-stroke hemiplegic patient. 1. A method for upper limb recovery. Clinical Rehabilitation 17: 88–95.
evaluation of physical performance. Scandinavian Journal
Patrick E, Ada L (2006) The Tardieu Scale differentiates
of Rehabilitation Medicine 7: 13–31.
contracture from spasticity whereas the Ashworth Scale is
Fujiwara T, Kasashima Y, Honaga K, Muraoka Y, Tsuji T, confounded by it. Clinical Rehabilitation 20: 173–182.
Osu R, et al (2009) Motor improvement and corticospinal
Paulis WD, Horemans HL, Brouwer BS, Stam HJ (2011)
modulation induced by hybrid assistive neuromuscular
Excellent test-retest and inter-rater reliability for Tardieu
dynamic stimulation (HANDS) therapy in patients with
Scale measurements with inertial sensors in elbow flexors
chronic stroke. Neurorehabilitation & Neural Repair 23:
of stroke patients. Gait & Posture 33: 185–189.
125–132.
Pomeroy VM, King L, Pollock A, Baily-Hallam A, Langhorne
Gamble GE, Barberan E, Laasch HU, Bowsher D, Tyrrell PJ,
P (2006) Electrostimulation for promoting recovery of
Jones AK (2002) Poststroke shoulder pain: a prospective
movement or functional ability after stroke. Cochrane
study of the association and risk factors in 152 patients from
Database of Systematic Reviews CD003241.
a consecutive cohort of 205 patients presenting with stroke.
European Journal of Pain 6: 467–474. Price CI, Pandyan AD (2000) Electrical stimulation for

Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013 253


Research

preventing and treating post-stroke shoulder pain. Cochrane Turton AJ, Britton E (2005) A pilot randomized controlled trial
Database of Systematic Reviews CD001698. of a daily muscle stretch regime to prevent contractures in
Roosink M, Renzenbrink GJ, Buitenweg JR, Van Dongen RT, the arm after stroke. Clinical Rehabilitation 19: 600–612.
Geurts AC, IJzerman MJ (2011) Persistent shoulder pain Urban PP, Wolf T, Uebele M, Marx JJ, Vogt T, Stoeter P, et al
in the first 6 months after stroke: results of a prospective (2010) Occurrence and clinical predictors of spasticity after
cohort study. Archives of Physical Medicine & Rehabilitation ischemic stroke. Stroke 41: 2016–2020.
92: 1139–1145.
van Kuijk AA, Hendricks HT, Pasman JW, Kremer BH, Geurts
Sirtori V, Corbetta D, Moja L, Gatti R (2009) Constraint-induced AC (2007) Are clinical characteristics associated with upper-
movement therapy for upper extremities in stroke patients. extremity hypertonia in severe ischaemic supratentorial
Cochrane Database of Systematic Reviews CD004433. stroke? Journal of Rehabilitation Medicine 39: 33–37.
Sunderland A, Tinson D, Bradley L, Hewer RL (1989) Arm Van Peppen R, Kwakkel G, Harmeling-van der Wel B, Kollen B,
function after stroke. An evaluation of grip strength as a Hobbelen J, Buurke J, et al (2004) KNGF Clinical Practice
measure of recovery and a prognostic indicator. Journal of Guideline for physical therapy in patients with stroke. Review
Neurology, Neurosurgery and Psychiatry 52: 1267–1272. of the evidence. Nederlands Tijdschrift voor Fysiotherapie
Turner-Stokes L, Jackson D (2006) Assessment of shoulder 114: suppl.
pain in hemiplegia: sensitivity of the ShoulderQ. Disability & Wade DT, Langton-Hewer R, Wood VA, Skilbeck CE, Ismail
Rehabilitation 28: 389-395. HM (1983) The hemiplegic arm after stroke: measurement
Turner-Stokes L, Rusconi S (2003) Screening for ability to and recovery. Journal of Neurology, Neurosurgery and
complete a questionnaire: a preliminary evaluation of the Psychiatry 46: 521–524.
AbilityQ and ShoulderQ for assessing shoulder pain in Wanklyn P, Forster A, Young J (1996) Hemiplegic shoulder
stroke patients. Clinical Rehabilitation 17: 150–157. pain (HSP): natural history and investigation of associated
features. Disability & Rehabilitation 18: 497–501.

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