Clinical trial NCT06452472: Observational Study of People with Complete Hand Amputation Using a Multi-grip Myoelectric Prosthesis a Following Using a Standard Myoelectric Prosthesis
Official title: Observational Study of People with Complete Hand Amputation Using a Multi-grip Myoelectric Prosthesis a Following Using a Standard Myoelectric Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation of Upper Limb
Keywords: Amputation of upper limb
Observational Study
I-LIMB
multi-grip myoelectric hand prosthesis
function
Lead sponsor: Össur Iceland ehf
Sponsor class: INDUSTRY
Collaborators: name: Clin-Experts
First posted: 2024-06-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators involved in the study are all doctors specializing in the fitting of limb amputee subjects. The study is conducted in French physical medicine and rehabilitation centers.

Brief summary: Cases of unilateral or bilateral upper limb amputation result in functional and aesthetic disability and a marked deterioration in quality of life. Amputees may use no prostheses, or use a combination of cosmetic prostheses, body-powered prostheses, or myoelectric prostheses (MHP). Among MHP, there are standard MHPs with a single degree of freedom (DOF) and one grip type, and multi-grip myoelectric hand (MG-MHP) with multiple DOF.

Amputees who do not use a prosthesis or a cosmetic prosthesis appear to have more difficulties in their daily activities and a greater disability than those who use body powered or myoelectric prostheses. While theoretically a MG-MHP offers the potential for subjects to perform more natural movements than a standard MHP, clinical evidence substantiating the advantages of MG-MHP over standard MHP in daily life remains inconclusive.

It remains essential to compare the advantages of MG-MHPs versus standard MHPs regarding functionality in daily life, quality of life and overall satisfaction among subjects who agree to transition from their standard MHP to a MG-MHP. The primary objective of this study was to assess upper limb function (specifically, the upper limb function component of the Orthotics and Prosthetics Users' Survey (OPUS) questionnaire) provided by a specific MG-MHP, i-Limb®, compared to a standard MHP in subjects with complete hand amputation.

The subjects participating in the study were patients equipped with MHP, coming to the center for a MG-MHPs hand test. If the prescription for the MG-MHPs hand was validated, the patient was then followed in the study for 8 to 10 weeks.


Eligibility criteria: Inclusion Criteria:

* Patient aged over 18 years old
* Patient with a unilateral acquired or congenital complete amputation
* Patient using a standard myoelectric hand prosthesis for at least 4 weeks
* Patient who has an indication of a Multi-Grip Myoelectric Hand Prosthesis , according to a multidisciplinary team

Exclusion Criteria:

* Pregnant women
* Patient under guardianship
* Patient with multiple amputations

Primary outcomes:
measure: Change in daily living with his/her prosthesis
timeFrame: at 8-10 weeks
Secondary outcomes:
measure: Change in the quality-of-life with his/her prosthesis
timeFrame: at 8-10 weeks
measure: Change is the satisfaction of the patient with his/her prosthesis
timeFrame: at 8-10 weeks
measure: Change is the satisfaction of the patient to the services provided assessed with OPUS
timeFrame: at 8-10 weeks
measure: Change in satisfaction of the patient assessed with ESAT
timeFrame: at 8-10 weeks
measure: Change in the Quick-DASH functional scale
timeFrame: at 8-10 weeks
measure: Change in the overall satisfaction of the patient on a Likert scale
timeFrame: at 8-10 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: France
facility: Multiples Facilities
Study officials:
affiliation: IRR - Établissement de Nancy - Louis-Pierquin
name: Isabelle LOIRET, MD
role: PRINCIPAL_INVESTIGATOR
References: