Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2018-05-15
2019-04-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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AFO (ankle foot orthosis) dynamic and correctional
Groep A with AFO (ankle foot orthosis) dynamic and correctional
Ankle Foot Orthosis (AFO)
3D treatment (AFO will be printed) versus traditional made AFO
AFO or KAFO (knee ankle foot orthosis) correctional
Groep B with AFO or KAFO (knee ankle foot orthosis) and only correctional
No interventions assigned to this group
KAFO dynamic and correctional
Groep C with KAFO dynamic and correctional
Knee Ankle Foot Orthosis (KAFO)
3D treatment (KAFO will be printed) versus traditional made KAFO
KAFO correctional
Groep D with KAFO only correctional
No interventions assigned to this group
Interventions
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Ankle Foot Orthosis (AFO)
3D treatment (AFO will be printed) versus traditional made AFO
Knee Ankle Foot Orthosis (KAFO)
3D treatment (KAFO will be printed) versus traditional made KAFO
Eligibility Criteria
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Inclusion Criteria
* Both unilateral and bilateral orthoses are included
* Pathology: genu varum
Exclusion Criteria
* The patient cannot stand upright
* The patient is pregnant
4 Years
ALL
No
Sponsors
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Handicap International
OTHER
Lieven De Maesschalck
OTHER
Responsible Party
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Lieven De Maesschalck
Innovation Manager
Locations
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CNAOM
Bamako, , Mali
Centre Hospitalier Universitaire de Niamey
Niamey, , Niger
CRAO
Dapaong, , Togo
CNAO
Lomé, , Togo
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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S65004
Identifier Type: -
Identifier Source: org_study_id
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