3D-printing and Acces to Tele Rehabilitation

Study Overview
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Brief Summary
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This study will investigate whether 3D printing of orthoses (night splints and AFO/KAFO for walking, further named as dynamic AFO/KAFO) for the lower limbs can help to improve the limited accessibility to orthopaedic devices in developing countries. The 3D printed orthoses will be assessed for effectiveness, cost and feasibility. Measurement and manufacture of the orthoses is also supported remotely via video conferencing.

Detailed Description
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Specifically, the study is being conducted in 3 West African countries: Togo, Niger and Mali. A total of 4 orthopaedic centres are involved, whereby an equal number of patients are recruited everywhere. There are 2 groups of patients, those who need a (knee) ankle-foot orthosis to move around (dynamic AFO/KAFO) and those who need a night splint to correct the ankle or knee position. All patients in the study will have a treatment route involving fitting a new traditional orthosis and a new 3D printed orthosis. The order of application of both treatments will be randomised in a crossover design. Patients will be measured at baseline after the first treatment period (3 weeks) and after the second treatment period (6 weeks). The primary outcome measures are different for both groups of patients: the walking speed when performing the 10-metre walk test in the patients wearing the dynamic AFO/KAFO, and the measured angle (of knee or ankle) in the patients wearing a night splint.

Official Title
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IMPression 3D & ACcès à la Teléréadaptation / 3D-printen en Toegang Tot Telerevalidatie

Conditions
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Orthopedic Disorder

Intervention / Treatment
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* Device: Ankle Foot Orthosis (AFO)
* Device: Knee Ankle Foot Orthosis (KAFO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathology: foot stance abnormality Both unilateral and bilateral orthoses are included Pathology: genu varum Exclusion Criteria: Patient is already wearing a night splint The patient cannot stand upright The patient is pregnant

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFO (ankle foot orthosis) dynamic and correctional<br>Groep A with AFO (ankle foot orthosis) dynamic and correctional | Device: Ankle Foot Orthosis (AFO)<br>* 3D treatment (AFO will be printed) versus traditional made AFO<br>|
| No Intervention: AFO or KAFO (knee ankle foot orthosis) correctional<br>Groep B with AFO or KAFO (knee ankle foot orthosis) and only correctional | |
| Experimental: KAFO dynamic and correctional<br>Groep C with KAFO dynamic and correctional | Device: Knee Ankle Foot Orthosis (KAFO)<br>* 3D treatment (KAFO will be printed) versus traditional made KAFO<br>|
| No Intervention: KAFO correctional<br>Groep D with KAFO only correctional | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter walk test | 10 meter walk test | 5 weeks | 
| knee angle test | Knee angle test | 5 weeks | 
| Ankle angle test | Ankle angle test | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OPUS questionnnaire | OPUS questionnnaire (measure on 5 point Likertscale: Very easy, Easy, Slightly difficult, Very difficult and Cannot do this activity and this for 21 items. | 5 weeks | 
| Range of motion | Range of motion | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lower limb