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

NCT05579002 | Completed

• 1 other identifier: CEREFAM-EFPHA-001
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Agenesis; Forearm; Malformation; Upper limb malformation; Prosthesis; Children; limb malformation; pediatric; Transverse agenesis of the forearm

Outcome Measures

Primary Outcomes (3)

• Canadian Occupational Performance Measure (MCRO) / change is being assessed

  Designed to detect, from the patient's own words, the disturbances in the occupational balance that occur in the areas of personal care, productivity and leisure. This assessment highlights problems and limitations in the child's participation in meaningful activities. The child must rate his or her performance, i.e., his or her perception of his or her ability to perform the activity, as well as his or her satisfaction with this performance. The child can describe up to 15 problematic items with an estimation on a 10-point ordinal scale (rating) of the importance of the difficulties identified. The examiner, with the child's input, will select the 5 most important difficulties to address. The child will self-assess on a 10-point scale, for each of the selected difficulties, his/her current performance ("I am capable or not") and satisfaction ("I am happy or not"). These are meaningful activities for the child at that age. This measure assessed change between T0 and T1.

  T0 at first use of the prosthesis and T1 at 12 months of use

• Disability of the Arm, Shoulder and Hand (DASH) / change is being assessed

  It was designed to be a region-specific instrument to measure the patient's perception of symptoms and disabilities associated with any upper extremity or joint disorder. We used it as a global functional assessment of the child, to evaluate what he or she is able to do with or without a prosthesis. The DASH consists of 30 items that measure: (a) physical abilities (21 items); (b) symptom severity (5 items) and (c) social abilities or roles (4 items). The DASH is scored using a 5-point Likert scale that rates the individual's difficulties in the previous week. This measure assessed change between T0 and T1

  T0 at first use of the prosthesis and T1 at 12 months of use

• Action Research Arm Test (ARAT) / change is being assessed

  ARAT is a measurement scale for assessing specific changes in limb function in individuals with brain injury (the result being hemiplegia). It assesses the patient's ability to manipulate objects of various sizes, weights, and shapes and can thus be considered a measure of upper extremity-specific activity limitations. The ARAT is divided into four subscales: Grasping; Grasping; Pinching; and Gross Motor Skills. Each subscale is a hierarchical Guttman scale, which means that each item is given in increasing order of difficulty. In the ARAT, if the patient successfully completes the most difficult item on the subscale, this suggests that he or she will succeed on the easier items on that same subscale. Similarly, failure on any item suggests that the patient will be unable to complete the more difficult items on that subscale. This measure assessed change between T0 and T1

  T0 at first use of the prosthesis and T1 at 12 months of use

Secondary Outcomes (2)

• The 400-point balance sheet / change is being assessed

  T0 at first use of the prosthesis and T1 at 12 months of use

• Analytical Questionnaire / change is being assessed

  T0 at first use of the prosthesis and T1 at 12 months of use

Study Arms (1)

Children with unilateral upper limb malformation

Children born between 2006 and 2012, with a unilateral upper limb deformity. These children are regularly followed at CEREFAM for a unilateral upper limb deformity. During their follow-up, they were fitted with different upper limb prostheses. During a consultation with one of the CEREFAM physicians, they requested a Hero Arm prosthesis following the marketing and reimbursement in France in 2019.

Other: Questionnaires and tests

Interventions

Questionnaires and tests OTHER

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.

Also known as: Application of questionnaires + analytical and functional tests

Children with unilateral upper limb malformation

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We include children born between 2006 and 2012 with a unilateral upper limb malformation. These children are regularly followed at CEREFAM for a unilateral upper limb deformity. During their follow-up, they requested a Hero Arm prosthesis.

You may qualify if:

• 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

You may not qualify if:

• Children with bilateral upper limb malformation
• Children with cognitive disorders who are not able to learn to use a myoelectric prosthesis

Sponsors & Collaborators

• Hopitaux de Saint-Maurice: lead

Study Sites (1)

Hôpitaux de Saint-Maurice

Saint-Maurice, Île-de-France Region, 94410, France

Location

Related Publications (5)

• de Jong IG, Reinders-Messelink HA, Janssen WG, Poelma MJ, van Wijk I, van der Sluis CK. Mixed feelings of children and adolescents with unilateral congenital below elbow deficiency: an online focus group study. PLoS One. 2012;7(6):e37099. doi: 10.1371/journal.pone.0037099. Epub 2012 Jun 8.

  PMID: 22715362 BACKGROUND

• Kerver N, van Twillert S, Maas B, van der Sluis CK. User-relevant factors determining prosthesis choice in persons with major unilateral upper limb defects: A meta-synthesis of qualitative literature and focus group results. PLoS One. 2020 Jun 30;15(6):e0234342. doi: 10.1371/journal.pone.0234342. eCollection 2020.

  PMID: 32603326 BACKGROUND

• Widehammar C, Pettersson I, Janeslatt G, Hermansson L. The influence of environment: Experiences of users of myoelectric arm prosthesis-a qualitative study. Prosthet Orthot Int. 2018 Feb;42(1):28-36. doi: 10.1177/0309364617704801. Epub 2017 May 4.

  PMID: 28470129 BACKGROUND

• Cordella F, Ciancio AL, Sacchetti R, Davalli A, Cutti AG, Guglielmelli E, Zollo L. Literature Review on Needs of Upper Limb Prosthesis Users. Front Neurosci. 2016 May 12;10:209. doi: 10.3389/fnins.2016.00209. eCollection 2016.

  PMID: 27242413 BACKGROUND

• Manero A, Smith P, Sparkman J, Dombrowski M, Courbin D, Kester A, Womack I, Chi A. Implementation of 3D Printing Technology in the Field of Prosthetics: Past, Present, and Future. Int J Environ Res Public Health. 2019 May 10;16(9):1641. doi: 10.3390/ijerph16091641.

  PMID: 31083479 RESULT

MeSH Terms

Conditions

Congenital Abnormalities; Limb Deformities, Congenital

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nathaly QUINTERO-PRIGENT, Doctor

  Centre de Référence pour les Anomalies des Membres (CEREFAM)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: January 2, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: February 20, 2026

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)