3D-printing and Acces to Tele Rehabilitation

Not Applicable

Completed

• Conditions: Orthopedic Disorder
• Interventions: Device: Ankle Foot Orthosis (AFO); Device: Knee Ankle Foot Orthosis (KAFO)

• Registration Number: NCT05947630
• Lead Sponsor: Lieven De Maesschalck

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.

Study Timeline

• Study Start: 2018-05-15
• Primary Completion: 2018-10-31
• Study Completion: 2019-04-15
• Study First Submitted: 2021-10-07
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-07
• Last Update Submitted: 2023-07-07
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AFO (ankle foot orthosis) dynamic and correctional	Ankle Foot Orthosis (AFO)	Groep A with AFO (ankle foot orthosis) dynamic and correctional
KAFO dynamic and correctional	Knee Ankle Foot Orthosis (KAFO)	Groep C with KAFO dynamic and correctional

Primary Outcome Measures

Name	Time	Method
Ankle angle test	5 weeks	Ankle angle test
10 meter walk test	5 weeks	10 meter walk test
knee angle test	5 weeks	Knee angle test

Secondary Outcome Measures

Name	Time	Method
Range of motion	5 weeks	Range of motion
OPUS questionnnaire	5 weeks	OPUS questionnnaire (measure on 5 point Likertscale: Very easy, Easy, Slightly difficult, Very difficult and Cannot do this activity and this for 21 items.

Trial Locations

Locations (4)

CRAO; 🇹🇬 Dapaong, Togo

CNAO; 🇹🇬 Lomé, Togo

CNAOM; 🇲🇱 Bamako, Mali

Centre Hospitalier Universitaire de Niamey; 🇳🇪 Niamey, Niger