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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04937179
Other study ID # 2021-0223
Secondary ID 20CDA35310419
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source University of Illinois at Chicago
Contact Lindsay Slater, PhD
Phone 3123558965
Email slaterlv@uic.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lower limb amputation is common in the United States, with approximately 150,000 amputations annually. Most individuals walking with a prosthesis demonstrate asymmetrical loading-i.e., they favor the amputated side by placing more weight and increased ground reaction forces through the intact limb-which likely contributes to increased metabolic cost of walking. Lack of adequate muscular strength in the lower limb to attenuate these forces places increased stress on the joints, which may be displaced proximally, and may play a role in reported knee and hip pain in the intact limb. Lower limb muscle weakness following amputation has been well documented. Increasing quadriceps strength is important after an amputation because it is positively correlated with gait speed. Gait speed may also be associated with successful community mobility, which leads to improved quality of life following amputation. Individuals with amputation who resume an active lifestyle are able to maintain strength. However, these individuals represent a minority of persons with lower limb amputation; most individuals report more barriers than motivators to adopt an active lifestyle. Ischemic conditioning (IC) may strengthen leg muscles and reduce the metabolic cost of activity after amputation. In IC, the limb is exposed to brief, repeated bouts of ischemia (reduced blood flow) immediately followed by reperfusion. IC has been shown to improve muscle performance in healthy and diseased populations. IC has also been used more recently in patients with peripheral artery disease (PAD) as an intervention to improve function, such as walking ability. Acute exposure to IC increases muscle strength and activation, both in healthy, active individuals and in those with severe neuromuscular dysfunction, such as stroke survivors. IC also attenuates muscular fatigue. Increased fatigue resistance at submaximal contraction levels following IC may be due to increased neural activation of skeletal muscle. Changes in neural activation of muscle may be particularly beneficial during cortical reorganization after amputation. Reduced quadriceps fatigue during submaximal activities may also drive changes in gait kinematics, such as increased knee flexion during loading and mid-stance. Exposure to IC may also increase the oxidative properties of skeletal muscle, offering a direct pathway to reduce metabolic cost. Therefore, IC may lead to cellular changes that lower the metabolic cost of activity. The primary aim of this study is to quantify the benefits of acute and chronic IC on quadriceps strength and walking economy in individuals with PAD and history of lower limb amputation.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years or older - Able to ambulate independently without the use of aids (i.e., walking cane) - Able to walk at least 10 minutes continuously without stopping - History of diagnosed peripheral artery disease. - For Amputees: History lower limb unilateral transtibial or transfemoral amputation. Exclusion Criteria: - Inability to give informed consent - neurological disorder that affects gait - two or more falls within the previous 12 months - 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 hypertension - history of heart failure - Head injury within the previous 6 months - Seizure disorder - Adverse reaction to ultrasound gel - History of thrombosis - History of sickle cell trait

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ischemic Conditioning Low - Sham Comparator
The use of a Hokanson rapid inflator cuff to restrict blood flow at 25mmHg for 5 minutes followed by a 5 minute reperfusion period, repeated for 5 cycles.
Ischemic Conditioning High - Active Comparator
The use of a Hokanson rapid inflator cuff to restrict blood flow at 225mmHg for 5 minutes followed by a 5 minute reperfusion period, repeated for 5 cycles.

Locations

Country Name City State
United States UIC Physical Therapy Faculty Practice Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Chicago American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in quadriceps strength Quadriceps strength assessed by a Biodex dynamometer through study completion, an average of 6 weeks
Primary Change in gait kinematics Gait mechanics assessed by joint angles using Vicon cameras and reflective markers through study completion, an average of 6 weeks
Primary Change in gait kinetics Gait mechanics assessed by joint forces using a Bertec instrumented treadmill in combination with gait kinematics through study completion, an average of 6 weeks
Primary Change in gait metabolics Assessment of oxygen consumption during walking using a metabolic cart through study completion, an average of 6 weeks
Secondary Six-minute walk test Measurement of distance walked in six minutes through study completion, an average of 6 weeks
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