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

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Device: Ankle Foot Orthosis (AFO); Device: Knee Ankle Foot Orthosis (KAFO)

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mali
  • Bamako, Mali
    • CNAOM
• Niger
  • Niamey, Niger
    • Centre Hospitalier Universitaire de Niamey
• Togo
  • Dapaong, Togo
    • CRAO
  • Lomé, Togo
    • CNAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AFO (ankle foot orthosis) dynamic and correctional; Groep A with AFO (ankle foot orthosis) dynamic and correctional	Device: Ankle Foot Orthosis (AFO); 3D treatment (AFO will be printed) versus traditional made AFO
No Intervention: AFO or KAFO (knee ankle foot orthosis) correctional; Groep B with AFO or KAFO (knee ankle foot orthosis) and only correctional
Experimental: KAFO dynamic and correctional; Groep C with KAFO dynamic and correctional	Device: Knee Ankle Foot Orthosis (KAFO); 3D treatment (KAFO will be printed) versus traditional made KAFO
No Intervention: KAFO correctional; Groep D with KAFO only correctional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 weeks
Range of motion	Range of motion	5 weeks

Collaborators and Investigators

• Sponsor: Lieven De Maesschalck
• Collaborators: Handicap International

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: lower limb
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: S65004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No