search
Back to results

3D-printing and Acces to Tele Rehabilitation (Imp&acte3D)

Primary Purpose

Orthopedic Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ankle Foot Orthosis (AFO)
Knee Ankle Foot Orthosis (KAFO)
Sponsored by
Lieven De Maesschalck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder focused on measuring lower limb

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CNAOM
  • Centre Hospitalier Universitaire de Niamey
  • CRAO
  • CNAO

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

AFO (ankle foot orthosis) dynamic and correctional

AFO or KAFO (knee ankle foot orthosis) correctional

KAFO dynamic and correctional

KAFO correctional

Arm Description

Groep A with AFO (ankle foot orthosis) dynamic and correctional

Groep B with AFO or KAFO (knee ankle foot orthosis) and only correctional

Groep C with KAFO dynamic and correctional

Groep D with KAFO only correctional

Outcomes

Primary Outcome Measures

10 meter walk test
10 meter walk test
knee angle test
Knee angle test
Ankle angle test
Ankle angle test

Secondary Outcome Measures

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.
Range of motion
Range of motion

Full Information

First Posted
October 7, 2021
Last Updated
July 7, 2023
Sponsor
Lieven De Maesschalck
Collaborators
Handicap International
search

1. Study Identification

Unique Protocol Identification Number
NCT05947630
Brief Title
3D-printing and Acces to Tele Rehabilitation
Acronym
Imp&acte3D
Official Title
IMPression 3D & ACcès à la Teléréadaptation / 3D-printen en Toegang Tot Telerevalidatie
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lieven De Maesschalck
Collaborators
Handicap International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder
Keywords
lower limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AFO (ankle foot orthosis) dynamic and correctional
Arm Type
Experimental
Arm Description
Groep A with AFO (ankle foot orthosis) dynamic and correctional
Arm Title
AFO or KAFO (knee ankle foot orthosis) correctional
Arm Type
No Intervention
Arm Description
Groep B with AFO or KAFO (knee ankle foot orthosis) and only correctional
Arm Title
KAFO dynamic and correctional
Arm Type
Experimental
Arm Description
Groep C with KAFO dynamic and correctional
Arm Title
KAFO correctional
Arm Type
No Intervention
Arm Description
Groep D with KAFO only correctional
Intervention Type
Device
Intervention Name(s)
Ankle Foot Orthosis (AFO)
Intervention Description
3D treatment (AFO will be printed) versus traditional made AFO
Intervention Type
Device
Intervention Name(s)
Knee Ankle Foot Orthosis (KAFO)
Intervention Description
3D treatment (KAFO will be printed) versus traditional made KAFO
Primary Outcome Measure Information:
Title
10 meter walk test
Description
10 meter walk test
Time Frame
5 weeks
Title
knee angle test
Description
Knee angle test
Time Frame
5 weeks
Title
Ankle angle test
Description
Ankle angle test
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
OPUS questionnnaire
Description
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
Title
Range of motion
Description
Range of motion
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CNAOM
City
Bamako
Country
Mali
Facility Name
Centre Hospitalier Universitaire de Niamey
City
Niamey
Country
Niger
Facility Name
CRAO
City
Dapaong
Country
Togo
Facility Name
CNAO
City
Lomé
Country
Togo

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28105945
Citation
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.
Results Reference
background

Learn more about this trial

3D-printing and Acces to Tele Rehabilitation

We'll reach out to this number within 24 hrs