- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07347561
A Comparison of Myoelectric and Bionic Hands
January 9, 2026 updated by: Güllü Aydın Yağcıoğlu, Gulhane School of Medicine
Myoelectric and Bionic Hands in Upper Limb Amputations: A Comparison of Body Image, Function and User Satisfaction
This observational study aims to compare myoelectric and bionic hands in terms of upper extremity function, body image and satisfaction.
The main questions it aims to answer are:
- Does upper extremity function differ between bionic and myoelectric hands?
The main questions it aims to answer are:
Does upper extremity function differ between bionic and myoelectric hands?
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Güllü AYDIN YAĞCIOĞLU, Asst. Prof
- Phone Number: +905536140823
- Email: gulluaydin23@gmail.com
Study Locations
-
-
Keçiören
-
Ankara, Keçiören, Turkey (Türkiye), 06010
- Recruiting
- University of Health Sciences Gülhane Faculty of Health Sciences
-
Contact:
- Güllü Yağcıoğlu
- Phone Number: 05536140823
- Email: gulluaydin23@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The study included individuals aged 8-65 who had undergone upper limb amputation.
Description
Inclusion Criteria:
- Aged 18 to 65 years
- Individuals with unilateral upper limb amputation
- Regular use of a prosthetic device for at least 6 months
- Use of a semi-electronic elbow joint prosthetic component
- Ability to understand and complete study assessments
Exclusion Criteria:
- Presence of bilateral or multiple limb amputations
- Proximal upper limb amputation at the shoulder level or above
- Coexisting neurological or orthopedic disorders that may affect upper limb function or study outcomes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Bionic Prosthetic Hand Group
Participants use advanced myoelectric prosthetic hands with multi-articulating structures and enhanced control features designed to improve functional performance.These devices are designed to enhance hand function, dexterity, and user interaction beyond conventional myoelectric control.
|
|
Myoelectric Prosthetic Hand Group
Participants in this group are individuals with upper limb amputation who use a myoelectric prosthetic hand controlled by surface electromyographic signals from residual limb muscles.
These devices provide electrically powered hand movement and basic grasp functions without advanced bionic or sensor-integrated features.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Limb Functionol Index-15
Time Frame: Baseline
|
The Upper Limb Functional Index-15 (ULFI-15) is a 15-item patient-reported outcome measure used to assess functional limitations related to the upper extremity.
It evaluates difficulties in daily activities, movement, and functional performance of the upper limb.
Higher scores indicate greater functional limitation.
|
Baseline
|
|
Amputee Body Image Scale
Time Frame: Baseline
|
The Amputee Body Image Scale (ABIS) is a self-reported questionnaire designed to assess body image perception and body-related concerns in individuals with limb amputation.
It measures the psychological impact of amputation on body image, with higher scores reflecting greater body image disturbance.
|
Baseline
|
|
Orthotics and Prosthetics Users' Survey
Time Frame: Baseline
|
The Orthotics and Prosthetics Users' Survey (OPUS) is a validated patient-reported outcome measure used to evaluate functional status, satisfaction, and quality of life in individuals using orthotic or prosthetic devices.
It assesses the user's perceived functional ability and satisfaction with their prosthetic device and related services.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Carey SL, Lura DJ, Highsmith MJ; CP; FAAOP. Differences in myoelectric and body-powered upper-limb prostheses: Systematic literature review. J Rehabil Res Dev. 2015;52(3):247-62. doi: 10.1682/JRRD.2014.08.0192.
- Kannenberg, A., Lundstrom, R., Hibler, K. D., & Johnson, S. S. (2023). Differences in two multiarticulating myoelectric hands for facilitating activities of daily living in individuals with transradial amputation: a cross-sectional study. JPO: Journal of Prosthetics and Orthotics, 35(1), 38-43.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2025
Primary Completion (Estimated)
February 15, 2026
Study Completion (Estimated)
March 15, 2026
Study Registration Dates
First Submitted
January 9, 2026
First Submitted That Met QC Criteria
January 9, 2026
First Posted (Estimated)
January 16, 2026
Study Record Updates
Last Update Posted (Estimated)
January 16, 2026
Last Update Submitted That Met QC Criteria
January 9, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- O&P
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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