Orthopedic Disorder
Conditions
Keywords
lower limb
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.
Interventions
3D treatment (AFO will be printed) versus traditional made AFO
DEVICEKnee Ankle Foot Orthosis (KAFO)
3D treatment (KAFO will be printed) versus traditional made KAFO
Sponsors
Handicap International
Lieven De Maesschalck
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10 meter walk test | 5 weeks | 10 meter walk test |
| knee angle test | 5 weeks | Knee angle test |
| Ankle angle test | 5 weeks | Ankle angle test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Range of motion | 5 weeks | Range of motion |
Countries
Mali, Niger, Togo
Outcome results
None listed