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Amputation of Upper LimbPROMISENCT06452472

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

An observational study of Amputation of Upper Limb, run by Össur Iceland ehf at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amputation of Upper Limb
What is being tested?
I-LIMB
Type of treatment
Medical device
How many people
25 participants
Where
1 siteFrance
Study dates
22 Jan 2019to 19 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Multiples Facilities

    Multiple Locations

Other trials in France

About this study

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.

Read more

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.

Being tested
I-LIMB
Keywords
Amputation of upper limb, Observational Study, I-LIMB, multi-grip myoelectric hand prosthesis, function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-LIMBDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at 8-10 weeks

Secondary outcomes (6)

  1. 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

    Measured: at 8-10 weeks

  2. 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.

    Measured: at 8-10 weeks

  3. 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

    Measured: at 8-10 weeks

  4. 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

    Measured: at 8-10 weeks

  5. 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.

    Measured: at 8-10 weeks

  6. 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)

    Measured: at 8-10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start22 Jan 2019
  3. Primary completion19 Dec 2022
  4. Study completion19 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06452472
Sponsor's protocol ID
2018-A02856-49
Acronym
PROMISE
Status last verified
Jun 2024
First submitted
5 Jun 2024
Last updated
4 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Amputation of Upper Limb, run by Össur Iceland ehf at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in daily living with his/her prosthesis (time frame: at 8-10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06452472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.

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PROMISE Clinical Trial NCT06452472 | AzTrials