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Completed
NCT05579002
Evaluation of the Functional Outcome of Hero Arm Prosthesis in Children After One Year of Use.
Conditions: Abnormality of Upper Lip
Sex: All
Ages: 7 Years – 16 Years
Enrollment: 10
Sponsor: Hopitaux de Saint-Maurice
Location: Hôpitaux de Saint-Maurice Saint-Maurice Île-de-France Region
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.
Eligibility Criteria
Inclusion Criteria:
* Children between 7 and 16 years old
* Children with a unilateral upper limb deformity
* Children with a Hero Arm bionic myoelectric prosthesis, with or without another prosthesis
* Children and parents who speak and understand French
* No objection to data collection
Exclusion Criteria:
* Children with bilateral upper limb malformation
* Children with cognitive disorders who are not able to learn to use a myoelectric prosthesis
Source: ClinicalTrials.gov (NCT05579002). StuddyBuddy aggregates publicly available trial information.