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Completed

NCT Number: NCT05947630

3D-printing and Acces to Tele Rehabilitation

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.

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Key information

Conditions

Orthopedic Disorder Musculoskeletal Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CNAOM, Bamako, Mali

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 10 meter walk test

    Time frame: 5 weeks

    10 meter walk test

  2. knee angle test

    Time frame: 5 weeks

    Knee angle test

  3. Ankle angle test

    Time frame: 5 weeks

    Ankle angle test

Secondary outcomes

  1. OPUS questionnnaire

    Time frame: 5 weeks

    OPUS questionnnaire (measure on 5 point Likertscale: Very easy, Easy, Slightly difficult, Very difficult and Cannot do this activity and this for 21 items.

  2. Range of motion

    Time frame: 5 weeks

    Range of motion

Sponsors and collaborators

Lead sponsor

Lieven De Maesschalck

Other

Collaborators

  • Handicap International

Registry information

Official study title

IMPression 3D & ACcès à la Teléréadaptation / 3D-printen en Toegang Tot Telerevalidatie

Acronym: Imp&acte3D

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 17, 2023
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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