An interventional study of Ankle Foot Orthosis (AFO) and Knee Ankle Foot Orthosis (KAFO) in Orthopedic Disorder, sponsored by Lieven De Maesschalck. Completed at 4 sites in 3 countries. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by Lieven De Maesschalck · Not applicable, Interventional, and Treatment
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.
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.
752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.
This study's enrollment of 79 is close to the median of 76 across 518 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Lieven De Maesschalck is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Groep A with AFO (ankle foot orthosis) dynamic and correctional
Device: Ankle Foot Orthosis (AFO)
Groep B with AFO or KAFO (knee ankle foot orthosis) and only correctional
Groep C with KAFO dynamic and correctional
Device: Knee Ankle Foot Orthosis (KAFO)
Groep D with KAFO only correctional
3D treatment (AFO will be printed) versus traditional made AFO
3D treatment (KAFO will be printed) versus traditional made KAFO
10 meter walk test
10 meter walk test
Time frame: 5 weeks
knee angle test
Knee angle test
Time frame: 5 weeks
Ankle angle test
Ankle angle test
Time frame: 5 weeks
OPUS questionnnaire
OPUS questionnnaire (measure on 5 point Likertscale: Very easy, Easy, Slightly difficult, Very difficult and Cannot do this activity and this for 21 items.
Time frame: 5 weeks
Range of motion
Range of motion
Time frame: 5 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Oct 2018, 5 months.
Of 251 non-industry interventional studies with no phase under Musculoskeletal Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 5 months is below that.
Counting every sponsor, half of 266 studies reached it within 16 months; a quarter within 6 and three quarters within 36.
Musculoskeletal Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Lieven De Maesschalck