Orthopedic DisorderImp&acte3DNCT05947630
3D-printing and Acces to Tele Rehabilitation
A study testing Ankle Foot Orthosis (AFO) and Knee Ankle Foot Orthosis (KAFO) in people with Orthopedic Disorder, run by Lieven De Maesschalck at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Ankle Foot Orthosis (AFO) and Knee Ankle Foot Orthosis (KAFO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 15 May 2018to 15 Apr 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathology: foot stance abnormality
- Both unilateral and bilateral orthoses are included
- Pathology: genu varum
Who cannot join
- Patient is already wearing a night splint
- The patient cannot stand upright
- The patient is pregnant
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Togo2 sites
CRAO
Dapaong
CNAO
Lomé
About this study
Official title: IMPression 3D & ACcès à la Teléréadaptation / 3D-printen en Toegang Tot Telerevalidatie
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.
Read the 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.
- Conditions
- Orthopedic Disorder
- Being tested
- Ankle Foot Orthosis (AFO), Knee Ankle Foot Orthosis (KAFO)
- Keywords
- lower limb
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Foot Orthosis (AFO)Device
3D treatment (AFO will be printed) versus traditional made AFO
Knee Ankle Foot Orthosis (KAFO)Device
3D treatment (KAFO will be printed) versus traditional made KAFO
| Study group | Role | What they receive |
|---|---|---|
| AFO (ankle foot orthosis) dynamic and correctional | Experimental | Groep A with AFO (ankle foot orthosis) dynamic and correctional Receives: Device: Ankle Foot Orthosis (AFO) |
| AFO or KAFO (knee ankle foot orthosis) correctional | No intervention | Groep B with AFO or KAFO (knee ankle foot orthosis) and only correctional |
| KAFO dynamic and correctional | Experimental | Groep C with KAFO dynamic and correctional Receives: Device: Knee Ankle Foot Orthosis (KAFO) |
| KAFO correctional | No intervention | Groep D with KAFO only correctional |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meter walk test
10 meter walk test
Measured: 5 weeks
knee angle test
Knee angle test
Measured: 5 weeks
Ankle angle test
Ankle angle test
Measured: 5 weeks
Secondary outcomes (2)
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.
Measured: 5 weeks
Range of motion
Range of motion
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start15 May 2018
- Primary completion31 Oct 2018
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lieven De Maesschalck
- Sponsor type
- University, hospital or other
- Collaborators
- Handicap International
- Responsible party
- Sponsor-investigator, Lieven De Maesschalck, Thomas More Kempen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947630
- Sponsor's protocol ID
- S65004
- Acronym
- Imp&acte3D
- Status last verified
- Jul 2023
- First submitted
- 7 Oct 2021
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28105945