3D-printing and Acces to Tele Rehabilitation
Imp&acte3D
IMPression 3D & ACcès à la Teléréadaptation / 3D-printen en Toegang Tot Telerevalidatie
1 other identifier
interventional
79
3 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2019
CompletedFirst Submitted
Initial submission to the registry
October 7, 2021
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedJuly 17, 2023
July 1, 2023
6 months
October 7, 2021
July 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
10 meter walk test
10 meter walk test
5 weeks
knee angle test
Knee angle test
5 weeks
Ankle angle test
Ankle angle test
5 weeks
Secondary Outcomes (2)
OPUS questionnnaire
5 weeks
Range of motion
5 weeks
Study Arms (4)
AFO (ankle foot orthosis) dynamic and correctional
EXPERIMENTALGroep A with AFO (ankle foot orthosis) dynamic and correctional
AFO or KAFO (knee ankle foot orthosis) correctional
NO INTERVENTIONGroep B with AFO or KAFO (knee ankle foot orthosis) and only correctional
KAFO dynamic and correctional
EXPERIMENTALGroep C with KAFO dynamic and correctional
KAFO correctional
NO INTERVENTIONGroep D with KAFO only correctional
Interventions
3D treatment (AFO will be printed) versus traditional made AFO
3D treatment (KAFO will be printed) versus traditional made KAFO
Eligibility Criteria
You may qualify if:
- Pathology: foot stance abnormality
- Both unilateral and bilateral orthoses are included
- Pathology: genu varum
You may not qualify if:
- Patient is already wearing a night splint
- The patient cannot stand upright
- The patient is pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lieven De Maesschalcklead
- Handicap Internationalcollaborator
Study Sites (4)
CNAOM
Bamako, Mali
Centre Hospitalier Universitaire de Niamey
Niamey, Niger
CRAO
Dapaong, Togo
CNAO
Lomé, Togo
Related Publications (1)
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.
PMID: 28105945BACKGROUND
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Innovation Manager
Study Record Dates
First Submitted
October 7, 2021
First Posted
July 17, 2023
Study Start
May 15, 2018
Primary Completion
October 31, 2018
Study Completion
April 15, 2019
Last Updated
July 17, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share