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Completed

NCT Number: NCT06452472

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

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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Key information

Conditions

Amputation of Upper Limb

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiples Facilities

Multiple Locations, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-LIMB

Device

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

Primary outcomes

  1. Change in daily living with his/her prosthesis

    Time frame: at 8-10 weeks

    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

Secondary outcomes

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

    Time frame: at 8-10 weeks

    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

  2. Change is the satisfaction of the patient with his/her prosthesis

    Time frame: at 8-10 weeks

    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.

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

    Time frame: at 8-10 weeks

    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

  4. Change in satisfaction of the patient assessed with ESAT

    Time frame: at 8-10 weeks

    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

  5. Change in the Quick-DASH functional scale

    Time frame: at 8-10 weeks

    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.

  6. Change in the overall satisfaction of the patient on a Likert scale

    Time frame: at 8-10 weeks

    Overall satisfaction on an 11-point Likert scale rated from 0 (not at all satisfied) to 10 (totally satisfied)

Sponsors and collaborators

Lead sponsor

Össur Iceland ehf

Industry

Collaborators

  • Clin-Experts

Registry information

Acronym: PROMISE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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