Last reviewed · How we verify
NCT05579002: EFPHA
Evaluation of the Functional Outcome of Hero Arm Prosthesis in Children After One Year of Use.
trial testing Questionnaires and tests in Abnormality of Upper Lip in 10 participants. Completed in 31 December 2023.
31 December 2022
Quick facts
| Lead sponsor | Hopitaux de Saint-Maurice |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 10 |
| Start date | 2 January 2022 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Questionnaires and tests
Conditions studied
- Abnormality of Upper Lip — all drugs for Abnormality of Upper Lip →
Sponsor
Hopitaux de Saint-Maurice
Who can join
Adults 7 to 16, any sex, with Abnormality of Upper Lip. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05579002
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05579002 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hopitaux de Saint-Maurice
- Last refreshed: 20 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05579002.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing