Physical Activity in Adults With Amputation (NCT03722797) | Clinical Trial Compass
TerminatedNot Applicable
Physical Activity in Adults With Amputation
Stopped: Equipment used for metabolic testing is no longer serviced and/or supported by the company. Alternative equipment is not available to the research team to continue to conduct the study.
United States3 participantsStarted 2017-05-11
Plain-language summary
This cross-sectional study explores physical activity and energy expenditure among inactive adults with a unilateral transtibial amputation. Results may assist with physical activity prescription for adults with unilateral lower-limb loss.
Who can participate
Age range
18 Years – 60 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 (all participants):
* Ages 18-60 years
* Able to read and speak English
* Saltin-Grimby Physical Activity Level of I or II
Inclusion Criteria (individuals with unilateral, transtibial amputations):
* Unilateral, transtibial (below-the-knee) amputation
* Currently wearing a prosthesis with use of an assistive device no greater than a cane
* Wearing prosthetic at least 8 hours per day and inside and outside the home: This criteria will help to ensure that adults are beyond the initial weaning into a prosthetic period and are prosthetic users rather than nonusers.
Inclusion Criteria (controls):
* Pain-free in the legs and low back regions
* Able to walk without an assistive device
Exclusion Criteria:
* Current infections or illnesses that would affect safe participation in the study
* Past medical history of significant cardiovascular disease (e.g. congestive heart failure or previous heart attacks), significant neurological disease (e.g. Parkinson's, Multiple Sclerosis) significant neurological event (e.g. stroke), or major lung condition (e.g. Chronic obstructive pulmonary disease, emphysema)
* Uncontrolled high blood pressure
* Uncontrolled Diabetes Mellitus
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.