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New treatment option for Traumatic Amputation of Lower Extremity
Official title Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss
ClinicalTrials.gov ID: NCT05929508
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Currently pregnant (or intend to become pregnant while participating in study).
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.