UIC Physical Therapy Faculty Practice
Chicago, Illinois, 60608, United States
Location status: Recruiting
NCT Number: NCT05929508
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60608, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A blood pressure cuff will be placed on the thigh of the intact/sound limb to restrict blood flow to the lower extremity for 5 minutes and then deflated for 5 minutes to allow for normal blood flow on a cycle for 50 minutes (5 times).
Time frame: through study completion, an average of 6 weeks
Comparing leg strength before and after intervention
Time frame: through study completion, an average of 6 weeks
Comparing leg strength before and after intervention
Time frame: through study completion, an average of 6 weeks
Comparing leg strength before and after intervention
Time frame: through study completion, an average of 6 weeks
Comparing leg strength before and after intervention
Time frame: through study completion, an average of 6 weeks
Comparing leg strength before and after intervention
Contact information is provided by the study sponsor or research team.
University of Illinois at Chicago
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02931396
Traumatic Amputation of Lower Extremity
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT05597696
Amputation, Traumatic Amputation of Lower Extremity
Ankara, Samanpazarı, Turkey (Türkiye)
View Trial DetailsNCT03027947
Nervous System Diseases, Neurobehavioral Manifestations
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT02540681
Traumatic Amputation of Lower Extremity
San Francisco, California, United States
View Trial Details