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

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.

Study Overview

• Status: Completed
• Conditions: Amputation of Upper Limb
• Intervention / Treatment: Device: I-LIMB

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• France
  • Multiple Locations, France
    • Multiples facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the quality-of-life with his/her prosthesis	Assessed with the OPUS quality of life score which includes 23 questions rated in 5 points. Questions 1 to 12 explore the subject's feelings on 12 aspects of their quality of life and interpersonal relationships, which are rated for overall feeling as follows: 4 None of the time; 3 A little of the time; 2 Some of the time ; 1 Most of the time ; 0 All the time. Questions 13 to 23 explore the subject's feelings about 11 aspects of their quality of life in terms of psychological experience and are rated as follow 4 all the time;3 Most of the time; 2 Some of the time; 1 A little of the time; 0 None of the time The total score is a minimum of 0 and a maximum of 92. The higher the score, the better the subject's quality of life	at 8-10 weeks
Change is the satisfaction of the patient with his/her prosthesis	Assessed with the prosthesis satisfaction dimension of the OPUS which includes 11 questions which explores 11 characteristics about the prosthesis. The questions are rated as follow: questions are rated as follows: 5 Strongly agree; 4 Agree; 3 Neither agree nor disagree : 2 Disagree; 1 Strongly disagree. The subject can answer "don't know". The total score is a minimum of 11 and a maximum of 55. The higher the score, the greater the subject's satisfaction with their prosthesis.	at 8-10 weeks
Change is the satisfaction of the patient to the services provided assessed with OPUS	Assessed with the satisfaction dimension relating to the services of the OPUS explores 10 characteristics associated with the services connected to the utilization of the prosthesis.. Questions are rated as follows: 5 Strongly agree; 4 Agree; 3 neither agree nor disagree; 2 Disagree; 1 Strongly disagree. The total score is a minimum of 10 and a maximum of 50. The higher the score, the greater the subject's satisfaction with their prosthesis	at 8-10 weeks
Change in satisfaction of the patient assessed with ESAT	Assess the change in satisfaction of the patient with Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); A higher score indicates higher satisfaction	at 8-10 weeks
Change in the Quick-DASH functional scale	The Quick DASH is an 11-item questionnaire designed to assess symptoms and functional limitations in individuals with upper limb disorders . It provides a 100% summative score, with 100 indicating the greatest handicap.	at 8-10 weeks
Change in the overall satisfaction of the patient on a Likert scale	Overall satisfaction on an 11-point Likert scale rated from 0 (not at all satisfied) to 10 (totally satisfied)	at 8-10 weeks

Collaborators and Investigators

• Sponsor: Össur Ehf
• Collaborators: Clin-Experts
• Investigators: Principal Investigator: Isabelle LOIRET, MD, IRR - Établissement de Nancy - Louis-Pierquin

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: function; Observational Study; Amputation of upper limb; I-LIMB; multi-grip myoelectric hand prosthesis
• Other Study ID Numbers: 2018-A02856-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No