3D-printing and Acces to Tele Rehabilitation

Orthopedic Disorder Clinical Trial

— Imp&acte3D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05947630
• Other study ID #: S65004
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: July 2023
• Source: Thomas More Kempen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 15, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Device:
• Ankle Foot Orthosis (AFO)
3D treatment (AFO will be printed) versus traditional made AFO
• Knee Ankle Foot Orthosis (KAFO)
3D treatment (KAFO will be printed) versus traditional made KAFO

Locations

Country	Name	City	State
Mali	CNAOM	Bamako
Niger	Centre Hospitalier Universitaire de Niamey	Niamey
Togo	CRAO	Dapaong
Togo	CNAO	Lomé

Sponsors (2)

Lead Sponsor	Collaborator
Lieven De Maesschalck	Handicap International

Countries where clinical trial is conducted

Mali,  Niger,  Togo, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10 meter walk test	10 meter walk test	5 weeks
Primary	knee angle test	Knee angle test	5 weeks
Primary	Ankle angle test	Ankle angle test	5 weeks
Secondary	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
Secondary	Range of motion	Range of motion	5 weeks