AmputationNCT07347561
A Comparison of Myoelectric and Bionic Hands
An observational study of Amputation and Upper Limb Amputation, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation, Upper Limb Amputation, Prosthesis
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 15 Mar 2026
- How long will I take part?
- 1 Day
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included individuals aged 8-65 who had undergone upper limb amputation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Gülhane Faculty of Health Sciences
Ankara, Keçiören, 06010
About this study
Official title: 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?
- Conditions
- Amputation, Upper Limb Amputation, Prosthesis
- Keywords
- Amputation, bionic hand, myoelectric hand, prosthesis, trans-humeral, trnas-radial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Functionol Index-15
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.
Measured: Baseline
Amputee Body Image Scale
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.
Measured: Baseline
Orthotics and Prosthetics Users' Survey
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Nov 2025
- Primary completion15 Feb 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güllü Aydın Yağcıoğlu, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347561
- Sponsor's protocol ID
- O&P
- Status last verified
- Nov 2025
- First submitted
- 9 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26230500Kannenberg, 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 at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myoelectric and Bionic Hands in Upper Limb Amputations: A Comparison of Body Image, Function and User Satisfaction
- ClinicalTrials.gov ID
- NCT07347561
- Acronym / sponsor ID
- O&P
- Conditions
- Amputation, Upper Limb Amputation, Prosthesis
- Keywords
- Amputation, bionic hand, myoelectric hand, prosthesis, trans-humeral, trnas-radial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included individuals aged 8-65 who had undergone upper limb amputation.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Results publication: PubMed 26230500Carey 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.
- Results publicationKannenberg, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Upper Limb Amputation, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 5 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 11 Sep 2026. 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 Turkey (Türkiye). 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?
Upper Limb Functionol Index-15 (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT07347561, which also lists 2 linked publications.
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 11 Sep 2026.