Clinical trial NCT05579002: Evaluation of the Functional Outcome of Hero Arm Prosthesis in Children After One Year of Use.
Official title: Evaluation of the Functional Outcome of a Bionic Myoelectric Prosthesis (Hero Arm) in Children With Upper Limb Agenesis After One Year of Use.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abnormality of Upper Lip
Keywords: Agenesis
Forearm
Malformation
Upper limb malformation
Prosthesis
Children
limb malformation
pediatric
Transverse agenesis of the forearm
Lead sponsor: Hopitaux de Saint-Maurice
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: Transverse forearm agenesis (TFA) is a sporadic, non-genetically based, mostly isolated congenital malformation. According to Froster-Iskenius U.G. \& Baird P.A, the incidence of this condition is estimated at 1.7 per 10,000 births. This condition is characterized by a lack of partial or complete development of a limb or limb segment. In transverse forearm agenesis (TFA), the majority of the damage occurs at the proximal-middle third of the limb.

In general, with the French administration, people with TFA are not considered to be disabled. However, this malformation can have a functional impact with limitations in certain activities of daily living and in the practice of specific activities (sports, music...). Socially, some patients present a desire to be "unnoticed", especially during adolescence and early adulthood, when entering professional life, for fear of discrimination in hiring. On the other hand, some patients display their malformation and even make it their "trademark".

Currently, agenesis patients are treated by multidisciplinary teams who propose a prosthesis. The prosthesis is not indispensable, patients live with their malformation since birth and are autonomous in their daily life. There are 3 categories of prostheses: aesthetic prostheses, functional prostheses and tool prostheses.

The Hero Arm prosthesis, belonging to the functional prostheses, is the first and only bionic myoelectric prosthesis reimbursed in France for children by the Social Security since 2019. This prosthesis is designed by 3D printing by Open Bionics in England. It is a prosthesis that has a lower cost than other prostheses available on the market, which is not negligible due to the growth of the child, requiring the change of prosthesis annually. The price of a Hero Arm prosthesis is around 12,000 to 15,000 euros. This prosthesis is a departure from traditional aesthetic prosthesis models and is closer to "superhero" type prostheses. In addition, there is a variety of colors available and the appearance can be customized by the children.

Until now, no study has been done on the functional results of the Hero Arm prosthesis in à pediatric context in France.

This is the first study on the use of a new bionic myoelectric prosthesis in children in France, retrospective, allowing to evaluate the service rendered by the medical device and the impact on the quality of life of these children with congenital amputation of the forearm. This study is based on the patients of the Reference Center for Limb Malformations (CEREFAM).

Beyond the functional aspect, this study will allow to frame the prescription of this prosthesis by analyzing the service rendered for the child and their family.

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

Primary outcomes:
measure: Canadian Occupational Performance Measure (MCRO) / change is being assessed
timeFrame: T0 at first use of the prosthesis and T1 at 12 months of use
measure: Disability of the Arm, Shoulder and Hand (DASH) / change is being assessed
timeFrame: T0 at first use of the prosthesis and T1 at 12 months of use
measure: Action Research Arm Test (ARAT) / change is being assessed
timeFrame: T0 at first use of the prosthesis and T1 at 12 months of use
Secondary outcomes:
measure: The 400-point balance sheet / change is being assessed
timeFrame: T0 at first use of the prosthesis and T1 at 12 months of use
measure: Analytical Questionnaire / change is being assessed
timeFrame: T0 at first use of the prosthesis and T1 at 12 months of use
Other outcomes:
Locations:
city: Saint-Maurice
country: France
facility: Hôpitaux de Saint-Maurice
state: Ile De France
Study officials:
affiliation: Centre de Référence pour les Anomalies des Membres (CEREFAM)
name: Nathaly QUINTERO-PRIGENT, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.