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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-22

Study Completion Date

2022-12-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Amputation of Upper Limb

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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I-LIMB

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

Intervention Type DEVICE

Eligibility Criteria

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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