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Observational Study of People with Complete Hand Amputation Using a Multi-grip Myoelectric Prosthesis a Following Using a Standard Myoelectric Prosthesis

NCT06452472 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2024-10-04

No results posted yet for this study

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.

Conditions

  • Amputation of Upper Limb

Interventions

DEVICE

I-LIMB

Use of a multi-grip myoelectric hand prosthesis (I-LIMB after using a standard myoelectric prosthesis)

Sponsors & Collaborators

  • Clin-Experts

    collaborator INDUSTRY

  • Össur Iceland ehf

    lead INDUSTRY

Principal Investigators

  • Isabelle LOIRET, MD · IRR - Établissement de Nancy - Louis-Pierquin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-22
Primary Completion
2022-12-19
Completion
2022-12-19

Countries

  • France

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06452472 on ClinicalTrials.gov