Clinical trial NCT05947630: 3D-printing and Acces to Tele Rehabilitation
Official title: IMPression 3D & ACcès à la Teléréadaptation / 3D-printen en Toegang Tot Telerevalidatie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Keywords: lower limb
Lead sponsor: Thomas More Kempen
Sponsor class: OTHER
Collaborators: name: Handicap International
First posted: 2023-07-17
Enrollment: 79
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 10 meter walk test
timeFrame: 5 weeks
measure: knee angle test
timeFrame: 5 weeks
measure: Ankle angle test
timeFrame: 5 weeks
Secondary outcomes:
measure: OPUS questionnnaire
timeFrame: 5 weeks
measure: Range of motion
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: CNAOM
city: Niamey
country: Niger
facility: Centre Hospitalier Universitaire de Niamey
city: Dapaong
country: Togo
facility: CRAO
city: Lomé
country: Togo
facility: CNAO
Study officials:
References:
citation: Creylman V, Knippels I, Janssen P, Biesbrouck E, Lechler K, Peeraer L. Assessment of transfemoral amputees using a passive microprocessor-controlled knee versus an active powered microprocessor-controlled knee for level walking. Biomed Eng Online. 2016 Dec 19;15(Suppl 3):142. doi: 10.1186/s12938-016-0287-6.