IMPression 3D & ACcès à la Teléréadaptation / 3D-printen en Toegang Tot Telerevalidatie
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Orthopedic Disorder
- Sponsor
- Lieven De Maesschalck
- Enrollment
- 79
- Locations
- 4
- Primary Endpoint
- Ankle angle test
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Lieven De Maesschalck
Innovation Manager
Thomas More Kempen
Eligibility Criteria
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
Outcomes
Primary Outcomes
Ankle angle test
Time Frame: 5 weeks
Ankle angle test
10 meter walk test
Time Frame: 5 weeks
10 meter walk test
knee angle test
Time Frame: 5 weeks
Knee angle test
Secondary Outcomes
- Range of motion(5 weeks)
- OPUS questionnnaire(5 weeks)