Prosthetics and Orthotics Manufacturing Guidelines: Lower Limb Orthotics: Ankle-Foot Orthosis
Prosthetics and Orthotics Manufacturing Guidelines: Lower Limb Orthotics: Ankle-Foot Orthosis
Prosthetics and Orthotics Manufacturing Guidelines: Lower Limb Orthotics: Ankle-Foot Orthosis
Ankle-Foot Orthosis
200
0868/002 09/2006 Physical Rehabilitation Programme
MISSION
The International Committee of the Red Cross (ICRC) is an impartial, neutral and
independent organization whose exclusively humanitarian mission is to protect the
lives and dignity of victims of war and internal violence and to provide them with
assistance. It directs and coordinates the international relief activities conducted
by the Movement in situations of conflict. It also endeavours to prevent suffering
by promoting and strengthening humanitarian law and universal humanitarian
principles. Established in 1863, the ICRC is at the origin of the International Red
Cross and Red Crescent Movement.
Acknowledgements:
Jean François Gallay
Leo Gasser
Pierre Gauthier
Frank Joumier
International Committee of the Red Cross Jacques Lepetit
19 Avenue de la Paix Bernard Matagne
1202 Geneva, Switzerland Joel Nininger
Guy Nury
T + 41 22 734 60 01 F + 41 22 733 20 57
Peter Poestma
E-mail: [email protected] Hmayak Tarakhchyan
www.icrc.org
© ICRC, September 2006 and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
All photographs: ICRC/PRP
Table of contents
Foreword 2
Introduction 4
Choosing between different designs 4
Casting and rectification 5
1. Flexible AFO 6
1.1 Moulding of EVA 6
1.2 Orthosis trim line 6
1.3 Vacuum moulding of the polypropylene 6
1.4 Preparation of the polypropylene shell 7
1.5 Preparation of the straps 8
1.6 Initial fitting and finishing 8
2. Rigid AFO 8
2.1 Moulding of EVA 8
2.2 Orthosis trim line 9
2.3 Plastic reinforcement 12
2.4 Vacuum moulding of the polypropylene 13
2.5 Preparation of the polypropylene shell 14
2.6 Proximal strap 14
2.7 Distal strap 15
2.8 Instep strap 16
2.9 Initial fitting and finishing 18
3. AFO with Tamarack Flexure JointTM 18
3.1 Moulding of EVA 18
3.2 Orthosis trim line 18
3.3 Plastic reinforcement 18
3.4 Installation of Tamarack Flexure JointTM 19
3.5 Vacuum moulding of the polypropylene 19
3.6 Preparation of the polypropylene shell 20
3.7 Preparation of the straps 22
3.8 Initial fitting and finishing 22
4. AFO anti-talus (anterior shell) 22
4.1 Moulding of EVA 22
4.2 Orthosis trim line 23
4.3 Plastic reinforcement 24
4.4 Vacuum moulding of the polypropylene 24
4.5 Preparation of the polypropylene shell 25
4.6 Preparation of the straps 26
4.7 Initial fitting 26
4.8 Finishing 26
List of manufacturing materials 27
Since its inception in 1979, the ICRC’s Physical Rehabilitation Programme has promoted the use
of technology that is appropriate to the specific contexts in which the organization operates,
i.e., countries affected by war and low-income or developing countries.
The technology must also be tailored to meet the needs of the physically disabled in the countries
concerned.
The choice of technology is of great importance for promoting sustainable physical rehabilitation
services.
For all these reasons, the ICRC preferred to develop its own technique instead of buying ready-made
orthopaedic components, which are generally too expensive and unsuited to the contexts in which
the organization works. The cost of the materials used in ICRC prosthetic and orthotic devices
is lower than that of the materials used in appliances assembled from commercial ready-made
components.
When the ICRC launched its physical rehabilitation programmes back in 1979, locally available
materials such as wood, leather and metal were used, and orthopaedic components were
manufactured locally. In the early 1990s the ICRC started the process of standardizing the
techniques used in its various projects around the world, for the sake of harmonization between the
projects, but more importantly to improve the quality of services to patients.
Polypropylene (PP) was introduced into ICRC projects in 1988 for the manufacture of prosthetic
sockets. The first polypropylene knee-joint was produced in Cambodia in 1991; other components
such as various alignment systems were first developed in Colombia and gradually improved. In
parallel, a durable foot, made initially of polypropylene and EthylVinylAcetate (EVA), and now of
polypropylene and polyurethane, replaced the traditional wooden/rubber foot.
In 1998, after careful consideration, it was decided to scale down local component production in
order to focus on patient care and training of personnel at country level.
The ICRC’s “Manufacturing Guidelines” are designed to provide the information necessary for
production of high-quality assistive devices.
This is another step forward in the effort to ensure that patients have access to high-quality services.
ICRC
Assistance Division/Health Unit
Physical Rehabilitation Programme
The aim of this document is to describe several methods for manufacturing ankle-foot orthoses
(AFO), working with the polypropylene technology used at the ICRC’s physical rehabilitation
centres.
Without going into details, some features of different types of AFO are set out below to assist in the
choice of design.
Flexible AFO
• Dorsiflexion assistance
• Poor medio-lateral stabilization of the subtalar joint
Rigid AFO
• Blocks ankle movements
• Mediolateral stabilization of the subtalar joint
• Possibility of controlling forefoot adduction/abduction
AFO anti-talus
• Blocks ankle movements. Particularly efficient for preventing ankle dorsiflexion
• Poor mediolateral stabilization of the subtalar joint
Patient assessment, casting and rectification of positive cast impressions are performed in
accordance with prosthetic and orthotic (P&O) standards.
For flexible AFO, the cast can be taken with 5 degrees of dorsiflexion so as to provide a preload and
ensure some spring action.
A flexible AFO does not usually require any EVA. However, in cases where it is necessary the
procedure described in section 2.1 (page 8) should be followed.
To achieve the goal of allowing dorsiflexion of the ankle while preventing passive plantar flexion,
there are a number of design options.
Heat the polypropylene at 180° for 20 to 25 minutes, depending on the thickness of the
polypropylene and the efficiency of the oven.
Drape the polypropylene over the plaster model and stick it together along the anterior side.
Tighten the polypropylene around the suction cone by means of a rope or something similar.
Draw the trim line on the polypropylene as described in section 1.2 (page 6).
For the proximal strap, follow the procedure described in section 2.6 (page 14).
A distal strap might be needed, depending on the capacity of the patient’s shoe to hold the foot
inside the orthosis. If this is needed, follow the procedure described in section 2.7 (page 15).
Carry out the required modification on the polypropylene and smooth the trim line.
Glue the EVA completely inside the polypropylene, cut off the surplus and smooth the trim line.
2 Rigid AFO
EVA (6 mm) may be moulded prior to the draping of the polypropylene, for the following reasons:
• to improve comfort;
• to prevent skin breakage in patients with sensation loss;
• for orthoses used at night.
Follow the procedure described below or, if the case does not require EVA, go on to the next section.
The AFO may need reinforcement, especially at ankle level. If necessary, use one of the following
methods; otherwise go on to the next section.
A double layer of polypropylene has the disadvantage of reducing flexibility of the forefoot in relation to
the metatarso-phalangeal joint.
The presence of channels in the plastic significantly improves its strength. There are several ways of
making these channels.
The more anterior the position of the channel, the more the AFO will resist dorsiflexion of the ankle.
Reinforcements prolonged along the side of the mid-foot increase the volume of the orthosis so that it
may no longer fit into the patient’s shoe.
If this has not yet been done, pull a stocking over the plaster model. For maximum efficiency, the EVA
used to make channels in the polypropylene must not be covered with a stocking.
Follow the procedure described in section 1.3 (page 6), taking into account the presence or absence
of a double layer of polypropylene (section 2.3.1, page 12).
Draw the trim line on the polypropylene as described in section 2.2 (page 9).
If EVA has been moulded beforehand, transfer the trim line to the EVA and cut off the excess with a
pair of scissors.
Use a ready-made Velcro strap 40 mm wide, or make a strap with Perlon webbing or some other
strong material.
You must choose between a distal strap and an instep strap. The latter has the advantage of holding
the calcaneum firmly inside the orthosis (equinus correction).
Two techniques are presented, depending on whether the back of the foot is in a neutral position or
needs a valgus/varus correction.
Carry out the required modifications on the polypropylene and smooth the trim line.
Glue the EVA completely inside the polypropylene, cut off the surplus and smooth the trim line.
Follow the procedure described in section 2.1 (page 8), or go on to the next section if EVA is not
required.
Posterior reinforcement for greater plantar flexion control is required when the orthosis is intended
to prevent plantar flexion (not fully described below).
Follow the procedure described below, or go on to the next section if plantar flexion is left free.
A second layer of polypropylene for positioning at the level of the Achilles tendon is moulded at the
same time as the main layer.
Make sure that the joints are at the same level on both sides.
Pull a stocking (cotton stockinet is too thick) over the plaster model.
Follow the procedure described in section 1.3 (page 6), taking into account the presence or absence
of a posterior reinforcement (section 3.3, page 18).
Draw the trim line on the polypropylene as explained in section 3.2 (page 18).
Cut only the contour of the orthosis with an oscillating saw. Do not cut along the separation between
foot section and calf section.
Extract the moulding dummies and the stocking from inside the AFO.
Smooth the trim line edge with a hand deburring tool or a piece of glass. Do not grind the trim line
because this will reduce flexure coverage and reduce the ability of the cavity to anchor and control the
flexure effectively.
For the proximal strap, follow the procedure described in section 2.6 (page 14).
In some cases the patient might need a distal strap. If so, follow the procedure described in section
2.7 (page 15).
Carry out the required modifications on the polypropylene and smooth the trim line.
Glue the EVA completely inside the polypropylene, cut off the excess and smooth the trim line.
Glue the flexure anchoring screws with a removable thread-locking compound (Loctite).
Do not cover the foot, to avoid an increase of volume which may prevent the patient from wearing
normal shoes.
Follow the procedure described below, or go on to the next section if the case does not require EVA.
The presence of channels in the plastic significantly improves its strength. There are several ways of
making these channels.
The procedure described below ensures uniform thickness of the polypropylene all over the orthosis. Do
not try to make a single seam on the anterior side, because the creases gathering at the ankle will make
it necessary to stretch the polypropylene too thinly.
If this has not yet been done, pull a stocking over the plaster model. For maximum efficiency the EVA
used to channel the polypropylene must not be covered with a stocking.
Drape the polypropylene over the plaster model and stick it together along the posterior side and
under the foot.
Tighten the polypropylene around the suction cone with a rope or something similar.
Draw the trim line on the polypropylene as explained in section 4.2 (page 23).
If EVA has been moulded beforehand, transfer the trim line to the EVA and cut off the excess with a
pair of scissors.
4.8 Finishing
Carry out the required modifications on the polypropylene and smooth the trim line.
Glue the EVA inside the polypropylene, cut off the surplus and smooth the trim line.
Unit of
ICRC Code Description Quantity
measure
For negative and positive cast :
ODROSTOCOT60 Tubular stockinet, 60 cm cm 70
According to size: Plaster of Paris bandages Piece 3
• MDREBANDP10 10, 12 or 15 cm x 3 m
• MDREBANDP12
• MDREBANDP15
OTOOPLASPW40 Plaster of Paris powder Each As required
For EVA and plastic moulding :
If required, according to EVA 6 mm Each As required
colour: Terra, olive or beige colour
• OPLAEVAFERA06
• OPLAEVAFLIV06
• OPLAEVAFKIN06
None Nylon stockinet Piece 1
According to colour and Homopolymer Each As required
thickness: Terra, olive or beige colour
• OPLAPOLYCHOC03 3, 4 or 5 mm thickness
• OPLAPOLYCHOC04
• OPLAPOLYCHOC05
• OPLAPOLYLIV03
• OPLAPOLYLIV04
• OPLAPOLYLIV05
• OPLAPOLYSKIN03
• OPLAPOLYSKIN04
• OPLAPOLYSKIN05
For the TAMARACK Flexure JointTM:
According to size: Piece 1
• OCPOSOOTTAL Large size (740L)
• OCPOSOOTTAS Small size (740S)
EHDWGLUEL243 Glue, Loctite 243, blue, threadlock, 50-ml bottle As required 4
For the proximal strap:
OSBOSTRVP440 Strap, Velcro, PVC, with loop, brown, 400 x 40 mm Piece 1
OHDWRIVET131 Rivet, tubular, 13 mm x 12 mm Piece 2
or
OSBOVSBO30 Strap, polyester, black, 40 mm cm 25
None Strap, Velcro, 40 mm cm 20
None Loop, 40 mm x 100 pieces Piece 1
OHDWRIVET131 Rivet, tubular, 13 mm x 12 mm Piece 2
For distal/instep strap:
OSBOSTRVP325 Strap, Velcro, PVC, with loop, brown, 300 mm x 25 mm Piece 1
OHDWRIVET131 Rivet, tubular, 13 mm x 12 mm Piece 2
or
OSBOVSBO24 Strap, Perlon webbing, 25 mm cm 20
None Strap, Velcro, 25 mm cm 15
OSBOVSBO35 Loop, 25 mm x 100 pieces Piece 1
OHDWRIVET131 Rivet, tubular, 13 mm x 12 mm Piece 2
Acknowledgements:
Jean François Gallay
Leo Gasser
Pierre Gauthier
Frank Joumier
International Committee of the Red Cross Jacques Lepetit
19 Avenue de la Paix Bernard Matagne
1202 Geneva, Switzerland Joel Nininger
Guy Nury
T + 41 22 734 60 01 F + 41 22 733 20 57
Peter Poetsma
E-mail: [email protected] Hmayak Tarakhchyan
www.icrc.org
© ICRC, September 2006 and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
All photographs: ICRC/PRP
Manufacturing Guidelines
Ankle-Foot Orthosis
200
0868/002 09/2006 Physical Rehabilitation Programme