Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Vo… (NCT05929508) | Clinical Trial Compass
RecruitingNot Applicable
Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss
United States30 participantsStarted 2024-04-01
Plain-language summary
The purpose of this study is to investigate the relationship between thigh strength and walking ability and assess if using a blood pressure cuff on the leg improves strength and walking performance.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years old
* History of lower limb unilateral transfemoral amputation.
* At least two years post lower limb amputation
* Able to ambulate independently without the use of aids (i.e., walking cane).
* Able to walk at least 10 minutes continuously without stopping.
* Has a safe residuum with no open wounds on either the residual or intact limb.
* Has a prosthetic limb with materials that are sound and safe to withstand the mobility requirements of the study.
Exclusion Criteria:
* Younger than 18 years old.
* Inability to give informed consent.
* Neurological disorder that affects gait.
* Participants with significant metal (greater than one orthopaedic screw) in either the residual limb or the sound/intact limb
* Participants who begin taking medications or change dosage of medications that could affect gait, balance, and cardiovascular function during the course of the study.
* Currently pregnant (or intend to become pregnant while participating in study).
* History of any condition where fatiguing contractions or resisted leg contractions are contraindicated.
* Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. open wounds in the leg).
* History of uncontrolled hypertension.
* History of heart failure.
* Head injury within the previous 6 months.
* Seizure disorder.
* History of vascular disease.
* History of thrombosis.
* History of sickle cell trait.
* History of geneti…
What they're measuring
1
Strength
Timeframe: through study completion, an average of 6 weeks
2
Gait
Timeframe: through study completion, an average of 6 weeks
3
Metabolics
Timeframe: through study completion, an average of 6 weeks
4
Daily Steps/Activity
Timeframe: through study completion, an average of 6 weeks
5
Arterial Stiffness
Timeframe: through study completion, an average of 6 weeks