Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452472
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
Observational Study of People with Complete Hand Amputation Using a Multi-grip Myoelectric Prosthesis a Following Using a Standard Myoelectric Prosthesis
Sponsor:
Össur Ehf
Organization:
Össur Ehf
Study Overview
Official Title:
Observational Study of People with Complete Hand Amputation Using a Multi-grip Myoelectric Prosthesis a Following Using a Standard Myoelectric Prosthesis
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None