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

NCT06452472 | Completed

• 1 other identifier: 2018-A02856-49
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation of Upper Limb

Keywords

Amputation of upper limb; Observational Study; I-LIMB; multi-grip myoelectric hand prosthesis; function

Outcome Measures

Primary Outcomes (1)

• Change in daily living with his/her prosthesis

  Assessed with upper limb function component of the Orthotics and prosthetics Users 'Survey (OPUS) which includes 23 questions and explores the ease with which the subject performs 23 activities of daily living with his/her prosthesis. The questions are rated from 4 very easy; 3 Easy 2 Slightly difficult; 1 Very difficult; 0 Cannot perform activity. The total score ranges from a minimum of 0 to a maximum of 92. A higher score correlates with an enhanced perception of functional

  at 8-10 weeks

Secondary Outcomes (6)

• Change in the quality-of-life with his/her prosthesis

  at 8-10 weeks

• Change is the satisfaction of the patient with his/her prosthesis

  at 8-10 weeks

• Change is the satisfaction of the patient to the services provided assessed with OPUS

  at 8-10 weeks

• Change in satisfaction of the patient assessed with ESAT

  at 8-10 weeks

• Change in the Quick-DASH functional scale

  at 8-10 weeks

Interventions

I-LIMB DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Össur Iceland ehf: lead
• Clin-Experts: collaborator

Study Sites (1)

Multiples Facilities

Multiple Locations, France

Location

Study Officials

• Isabelle LOIRET, MD

  IRR - Établissement de Nancy - Louis-Pierquin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: January 22, 2019
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: October 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)