Clinical trial NCT05929508: Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss
Official title: Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Amputation of Lower Extremity
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: One in every 190 Americans is currently living with the loss of a limb. Following lower limb amputation (LLA), individuals have double the risk of knee and hip pain, a high prevalence of osteoarthritis in the intact limb with a prevalence ratio of 3.3 compared to those without amputation, and up to 90% experience severe back pain. The long-term consequences of LLA may be mitigated through regular use of prosthesis and physical activity, which would also increase the likelihood of returning to work and reintegration of Service Members (SMs) and younger Veterans.

Clinicians and researchers often focus on the prosthetic fit to improve outcomes, however just providing a prosthetic, even the most advanced prosthetic, is not enough to restore function. Interventions targeting physical capabilities to complement device intervention may be key to improving outcomes in individuals with LLA.

Along with increased orthopaedic risks, individuals with traumatic LLA also have an increased risk of cardiovascular events compared to the general population. SMs with traumatic unilateral transfemoral amputation have a 1.58 times greater risk of death from cardiovascular causes and their relative risk of aortic aneurysm is 5.1 times greater than Veterans without amputation. There is evidence to suggest that individuals with LLA have increased peripheral vascular resistance following amputation, leading to vasoconstriction and increased blood pressure. Reduced arterial function (i.e. increased arterial stiffness) is an important measure in those with LLA because it predicts mortality, heart failure, and cardiovascular events. In addition, improved arterial function improves perfusion to muscle and reduces fatigue during exertion. Therefore, strategies that reduce arterial stiffness and vascular resistance in individuals with LLA are important to improve mortality and quality of life for SMs and Veterans.

Therefore, we propose implementing ischemic preconditioning (IC) as a novel intervention to strengthen and hypertrophy leg muscles and increase arterial function for improving outcomes after amputation.

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

Primary outcomes:
measure: Strength
timeFrame: through study completion, an average of 6 weeks
measure: Gait
timeFrame: through study completion, an average of 6 weeks
measure: Metabolics
timeFrame: through study completion, an average of 6 weeks
measure: Daily Steps/Activity
timeFrame: through study completion, an average of 6 weeks
measure: Arterial Stiffness
timeFrame: through study completion, an average of 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: UIC Physical Therapy Faculty Practice
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Lindsay Slater
role: PRINCIPAL_INVESTIGATOR
References: