Abnormality of Upper LipEFPHANCT05579002
Evaluation of the Functional Outcome of Hero Arm Prosthesis in Children After One Year of Use.
An observational study of Abnormality of Upper Lip, run by Hopitaux de Saint-Maurice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Abnormality of Upper Lip
- What is being tested?
- Questionnaires and tests
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Child
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.
Who may be able to join
- 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
Who cannot join
- Children with bilateral upper limb malformation
- Children with cognitive disorders who are not able to learn to use a myoelectric prosthesis
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpitaux de Saint-Maurice
Saint-Maurice, Île-de-France Region, 94410
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Abnormality of Upper Lip
- Being tested
- Questionnaires and tests
- Keywords
- Agenesis, Forearm, Malformation, Upper limb malformation, Prosthesis, Children, limb malformation, pediatric, Transverse agenesis of the forearm
- Medical subject headings
- Congenital Abnormalities, Limb Deformities, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and testsOther
Also called Application of questionnaires + analytical and functional tests
Application of three questionnaires:
- Canadian Occupational Performance Measure (CORM),
- a version of the Disabilities of the Arm Shoulder and Hand (DASH) modified for the child
- a questionnaire developed by CEREFAM
- Two analytical and functional tests:
- the Action Research Arm Test (ARAT) 2) modified 400-point assessment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires and tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
This is a functional evaluation of the hand. It proposes an evaluation at 4 levels: motor skills, strength, single-handed grip, bi-manual coordination. Each test is scored out of 100.
A modification of the 400-point assessment, involving the use of tests 3 and 4 only, was carried out at the Percy Army Training Hospital to evaluate upper limb prostheses after traumatic amputation.
This modified version of the 400-point assessment therefore includes two parts instead of the four in the unmodified version:
Test 3: Evaluation of single-handed grasping and moving of objects. This is a timed test, where each hand will be timed.
Test 4: Evaluation of two-handed coordination. Non-timed test
This measure assessed change between T0 and T1
Measured: T0 at first use of the prosthesis and T1 at 12 months of use
Analytical Questionnaire / change is being assessed
Analytical questionnaire realized by the team of the CEREFAM of Saint Maurice.
It is divided into 6 parts:
- history of the use of à prostheses and reasons for stopping using prostheses in the past
- assesses the child's current use of the Hero Arm prosthesis
- Evaluates 5 criteria for Hero Arm satisfaction (aesthetics, fluidity of movement, maintenance, use, battery)
- assesses 9 Hero Arm disadvantage criteria (failure, battery position discomfort, weight tolerance, dressing discomfort, pain in use, skin damage and discomfort, sweat tolerance, and noise).
- Evaluate how the children feel about the prosthesis with an emotion scale
- The sixth part includes 4 open questions
This measure assessed change between T0 and T1
Measured: T0 at first use of the prosthesis and T1 at 12 months of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start2 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Abnormality of Upper LipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopitaux de Saint-Maurice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathaly QUINTERO-PRIGENT, Doctor, Study director, Centre de Référence pour les Anomalies des Membres (CEREFAM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579002
- Sponsor's protocol ID
- CEREFAM-EFPHA-001
- Acronym
- EFPHA
- Status last verified
- Aug 2026
- First submitted
- 10 Oct 2022
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31083479de 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.
PubMed 22715362Kerver 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.
PubMed 32603326Widehammar 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.
PubMed 28470129Cordella 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.
PubMed 27242413Eveilleau C, Lallemant-Dudek P, Meriot D, Chamberon M, Martinot-Lagarde C, Bachy M, Quintero-Prigent N. Functional abilities and desires for a bionic prosthesis in children with unilateral congenital below-elbow deficiency: An observational study. Prosthet Orthot Int. 2026 May 6. doi: 10.1097/PXR.0000000000000518. Online ahead of print.
PubMed 42114153
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05579002
- Acronym / sponsor ID
- EFPHA / CEREFAM-EFPHA-001
- Conditions
- Abnormality of Upper Lip
- Keywords
- Agenesis, Forearm, Malformation, Upper limb malformation, Prosthesis, Children, limb malformation, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hopitaux de Saint-MauriceUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with unilateral upper limb malformation | – | Other: Questionnaires and testsChildren 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. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Children with bilateral upper limb malformation
- Children with cognitive disorders who are not able to learn to use a myoelectric prosthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires and testsAlso: Application of questionnaires + analytical and functional testsApplication 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. | Other | Children with unilateral upper limb malformation |
Primary outcome
Canadian Occupational Performance Measure (MCRO) / change is being assessed
Time frame: T0 at first use of the prosthesis and T1 at 12 months of use
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.
Disability of the Arm, Shoulder and Hand (DASH) / change is being assessed
Time frame: T0 at first use of the prosthesis and T1 at 12 months of use
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
Action Research Arm Test (ARAT) / change is being assessed
Time frame: T0 at first use of the prosthesis and T1 at 12 months of use
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
2 secondary outcomes
The 400-point balance sheet / change is being assessed
Time frame: T0 at first use of the prosthesis and T1 at 12 months of use
Analytical Questionnaire / change is being assessed
Time frame: T0 at first use of the prosthesis and T1 at 12 months of use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 31083479Manero 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.
- Background: PubMed 22715362de 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.
- Background: PubMed 32603326Kerver 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.
- Background: PubMed 28470129Widehammar 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.
- Background: PubMed 27242413Cordella 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.
- Results publication: PubMed 42114153Eveilleau C, Lallemant-Dudek P, Meriot D, Chamberon M, Martinot-Lagarde C, Bachy M, Quintero-Prigent N. Functional abilities and desires for a bionic prosthesis in children with unilateral congenital below-elbow deficiency: An observational study. Prosthet Orthot Int. 2026 May 6. doi: 10.1097/PXR.0000000000000518. Online ahead of print.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaly QUINTERO-PRIGENT, Doctor study director
Centre de Référence pour les Anomalies des Membres (CEREFAM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormality of Upper Lip, run by Hopitaux de Saint-Maurice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (MCRO) / change is being assessed (time frame: T0 at first use of the prosthesis and T1 at 12 months of use). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05579002, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.