Feasibility of Implantable Myoelectric Sensors to Control Upper Limb Prostheses (NCT01901081) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Implantable Myoelectric Sensors to Control Upper Limb Prostheses
United States3 participantsStarted 2013-05
Plain-language summary
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control an electromechanical prosthetic wrist and hand.
Who can participate
Age range
18 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
. Patient is a health care beneficiary at the Walter Reed National Military Medical Center.
. Patient has transradial amputation with one-third or greater residual forearm length as determined by the contralateral side.
. Patient's residual forearm anatomy (based on number and size of residual muscles) will support the implantation and control of at least six IMES (in the opinion of the Investigator). This criterion will be verified during a study-specific screening test.
. Patient is age 18 or above.
. Patient can speak and comprehend English.
. Patient is willing and capable of providing informed consent.
. Patient has undergone amputee rehabilitation, including being trained to wear and use a body-powered and myoelectric prosthesis.
. Patient reports wearing an upper limb prosthesis at least two hours per day.
Exclusion criteria
. Patient is less than three months from amputation surgery or major injury of the target residual limb.
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
Device-Related Serious Adverse Events
Timeframe: Information collected over the course of 2 years following implant of IMES
2
Change in Accuracy Test score
Timeframe: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
Trial details
NCT IDNCT01901081
SponsorThe Alfred E. Mann Foundation for Scientific Research