3D-printing and Acces to Tele Rehabilitation (Imp&acte3D)

Lieven De Maesschalck

Status: Completed

Conditions: Orthopedic Disorder

Treatments: Device: Knee Ankle Foot Orthosis (KAFO); Device: Ankle Foot Orthosis (AFO)

Study type: Interventional

Funder types: Other

Identifiers

NCT05947630

S65004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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79 participants in 4 patient groups

AFO (ankle foot orthosis) dynamic and correctional

Experimental group

Description:

Groep A with AFO (ankle foot orthosis) dynamic and correctional

Treatment:

Device: Ankle Foot Orthosis (AFO)

AFO or KAFO (knee ankle foot orthosis) correctional

No Intervention group

Description:

Groep B with AFO or KAFO (knee ankle foot orthosis) and only correctional

KAFO dynamic and correctional

Experimental group

Description:

Groep C with KAFO dynamic and correctional

Treatment:

Device: Knee Ankle Foot Orthosis (KAFO)

KAFO correctional

No Intervention group

Description:

Groep D with KAFO only correctional