Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM (NCT01546675) | Clinical Trial Compass
CompletedNot Applicable
Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
United States2 participantsStarted 2012-01
Plain-language summary
The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization. The investigators comparisons included assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel high-speed, high-resolution, bi-plane video radiography system.
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:
* Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.
Exclusion Criteria:
* Subjects with frozen shoulder of the residual side, and/or severely limited active range of motion of the shoulder joint of the residual limb
* Inability to tolerate wearing of a prosthetic socket
* Mental impairment that renders a subject unable to comply with the study
* Skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevent prior prosthetic wear
* Any electrically controlled medical device including pacemaker, implanted defibrillator or drug pumps
* Neuropathy, uncontrolled diabetes, receiving dialysis
* Any other significant comorbidity which would interfere with the study
* Severe circulatory problems including peripheral vascular disease and pitting edema will be excluded
* Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
* Women who are pregnant or who plan to become pregnant in the near future
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
Degrees of Shoulder Abduction Within the Prosthetic Socket
Timeframe: After 4 weeks of home use (2 weeks for each socket style)
2
Degrees of Shoulder Internal Rotation Within the Prosthetic Socket
Timeframe: After 4 weeks of home use (2 weeks for each socket style)
3
Degrees of Shoulder Displacement Within the Prosthetic Socket
Timeframe: After 4 weeks of home use (2 weeks for each socket style)