Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Jun 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at ways to help improve strength and walking ability in individuals who have had a leg amputated above the knee, known as a transfemoral amputation. The researchers want to see if using a blood pressure cuff on the leg can help increase thigh strength and make it easier for participants to walk. This study is currently recruiting participants aged 18 and older who have been living with a prosthetic limb for at least two years and can walk independently for at least 10 minutes without stopping.

To participate, individuals must have a safe and healthy residual limb, meaning there are no open wounds or serious medical conditions that could make the study unsafe. Participants can expect to engage in activities that assess their strength and walking performance throughout the trial. It's important to note that certain health conditions, such as significant heart issues or recent head injuries, may prevent someone from participating. This trial aims to find new ways to enhance mobility and improve the quality of life for those with a lower limb amputation.

Gender

ALL

Eligibility criteria

• 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 genetic disease