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