Comparison of Standard Myoelectric Hand and Bionic Hand Use in Individuals With Upper Limb Amputa… (NCT06684730) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Standard Myoelectric Hand and Bionic Hand Use in Individuals With Upper Limb Amputation
Turkey (Türkiye)22 participantsStarted 2024-11-27
Plain-language summary
This single-center, prospective, comparative study aims to compare hand function, quality of life, patient satisfaction, task completion time, fatigue, and compensatory elbow, shoulder, and cervical movements in individuals with transradial amputation or wrist disarticulation who use either standard myoelectric or bionic hand prostheses. The primary research questions are:
1. Are there differences in patient satisfaction, quality of life, and hand function between individuals using standard myoelectric and bionic hand prostheses?
2. Do individuals using standard myoelectric and bionic hand prostheses exhibit different kinematics in terms of compensatory shoulder, elbow, and neck movements? Could bionic hand prostheses with their diverse grasping capabilities lead to fewer compensatory movements compared to standard myoelectric hand prostheses?
3. Can fatigue induced by performing specific activities of daily living alter hand function and upper extremity-neck kinematics in individuals using either standard myoelectric or bionic hand prostheses?
4. Can cognitive and physical fatigue following activities of daily living lead to different levels of changes in hand function and upper extremity-neck kinematics in individuals using standard myoelectric and bionic hand prostheses?
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Having a transradial amputation or wrist disarticulation due to acquired or congenital causes,
* Using a standard myoelectric or bionic hand prosthesis for at least 6 months,
* Being between the ages of 18 and 65,
* Having no neurological or cognitive disorders, rheumatic diseases, or other upper extremity dysfunction that could affect test results, and
* Having signed an informed consent form indicating the patient's willingness to participate in the study.
Exclusion Criteria:
* Individuals younger than 18 or older than 65,
* Those with additional musculoskeletal or neurological conditions preventing them from completing the tests and scales,
* Those with psychiatric disorders or cognitive impairments preventing them from completing the questionnaire and assessment scales,
* Those with stump or upper extremity conditions preventing them from using their prosthesis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Kinematical measurement of shoulder abduction
Timeframe: immediately before/after the parkour
Trial details
NCT IDNCT06684730
SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital