NCT05947630

3D-printing and Acces to Tele Rehabilitation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Lieven De Maesschalck · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthopedic Disorder

Interventions

Type	Name	Description
DEVICE	Ankle Foot Orthosis (AFO)	3D treatment (AFO will be printed) versus traditional made AFO
DEVICE	Knee Ankle Foot Orthosis (KAFO)	3D treatment (KAFO will be printed) versus traditional made KAFO

Timeline

• Start date: 2018-05-15
• Primary completion: 2018-10-31
• Completion: 2019-04-15
• First posted: 2023-07-17
• Last updated: 2023-07-17

Locations

4 sites across 3 countries: Mali, Niger, Togo