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Evaluation of the Functional Outcome of Hero Arm Prosthesis in Children After One Year of Use.

NCT05579002 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2026-02-20

No results posted yet for this study

Summary

The goal of this observational study is to evaluate the functional impact of using a bionic myoelectric prosthesis (Hero Arm) in children with a transverse forearm agenesis upper limb deformity, after one year of use. The Hero Arm prosthesis is the first bionic myoelectric prosthesis reimbursed in France for children.

The main objective is to Identify the functional difficulties encountered by the child related to the agenesis and which could be improved by wearing this prosthesis.

The investigators will include children born between 2006 and 2012 with a unilateral upper limb malformation. These children are regularly followed at Reference Center for Limb Malformations (CEREFAM) at the Saint-Maurice Hospitals (HSM) for a unilateral upper limb deformity. CEREFAM is currently following a large cohort of children with malformations including 143 children with transverse forearm agenesis. Of these, approximately 10% have been prescribed a Hero Arm prosthesis.

After the delivery of the Hero Arm, they are followed up in occupational therapy at HSM to learn how to use the prosthesis. This training lasts two days with an evaluation (T0). This assessment includes:

* three questionnaires: the Canadian Measure of Occupational Performance (CMOP), a version of the Disabilities of the Arm Shoulder and Hand (DASH) that has been modified to fit the child, and a questionnaire completed by the CEREFAM.
* two analytical and functional tests: the Action Research Arm Test (ARAT) and the modified 400-point assessment.

The same assessment will be performed after one year of wearing the prosthesis (T1).

This is a observational and non-interventional study. No changes have been made to the usual follow-up of the patient.

Conditions

  • Abnormality of Upper Lip

Interventions

OTHER

Questionnaires and tests

Application of three questionnaires: 1. Canadian Occupational Performance Measure (CORM), 2. a version of the Disabilities of the Arm Shoulder and Hand (DASH) modified for the child 3. a questionnaire developed by CEREFAM * Two analytical and functional tests: 1\) the Action Research Arm Test (ARAT) 2) modified 400-point assessment.

Sponsors & Collaborators

  • Hopitaux de Saint-Maurice

    lead OTHER

Principal Investigators

  • Nathaly QUINTERO-PRIGENT, Doctor · Centre de Référence pour les Anomalies des Membres (CEREFAM)

Eligibility

Min Age
7 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-02
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579002 on ClinicalTrials.gov