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Completed
NCT07910734
Supplemental Blood Flow Restriction Training to Improve the Upper Extremity in Chronic Stroke
Conditions: Cerebro-vascular Accident, Exercise, Blood Flow Restriction (BFR) Training Effects
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 16
Sponsor: Saint Joseph's University, Philadelphia
Location: Greg Thielman Philadelphia Pennsylvania
Summary
The leading cause of long-term disability worldwide is neurological conditions, with stroke specifically affecting nearly 800,000 individuals in the United States in 2019. These populations currently live with reduced functional ability due to reduced strength, motor control, and muscular endurance, thereby impairing their ability to perform tasks throughout the day. One of the common functional abilities lost is upper extremity (UE) function, which leads to decreased independence with activities of daily living (ADL), increased reliance on caregivers, and increased financial burden due to increased healthcare costs. Blood flow restriction therapy (BFR) is an innovative therapeutic intervention that may serve as a supplement to traditional interventions. Blood flow restriction therapy has shown promise in improving muscular hypertrophy, muscular strength, and functional outcome measures in those with and without neurologic conditions.
Eligibility Criteria
Inclusion Criteria: Between the ages of 18 and 65;
* Diagnosis of (\>1) CVA that occurred \>1 year prior to participation
* understand instructions of exercise activity
* Have a moderate motor impairment consistent with the results of the Fugl-Meyer for the upper extremity;
* Safe for use of BFR tourniquet device (see exclusion criteria);
* Able to elevate and hold a paretic arm for 2 seconds at 90° shoulder flexion, 160°-180° elbow extension, and neutral forearm supination;
* \>20° gravity minimized wrist extension while holding a cylindrical object on a tabletop.
Exclusion Criteria:
* Bone or joint limitations that restrict paretic arm motion;
* History of deep venous thrombosis, impaired circulation, or peripheral vascular compromise,
* previous revascularization of the extremity, extremities with dialysis access, acidosis, extremity infection or tumor distal to tourniquet,
* increased intracranial pressure, severe hypertension, any traumatic surgery or reconstruction of extremity distal to tourniquet,
* skin grafts, lengthy immobilization of extremity, surgery or damage to lymph structures associated with paretic extremity, myocardial infarction or cardiac surgery,
* chest pain
* shortness of breath at rest or active cancer;
* Currently taking or using medications and supplements known to increase clotting risk \< 1 month prior to participation;
* Currently experiencing or at risk for a hypercoagulable state
* Botox injections into the paretic arm within 4 months of participation
* Positive classification on the Edinburgh Claudication Questionnaire Score \> 0 on Wells' criteria for DVT.
Source: ClinicalTrials.gov (NCT07910734). StuddyBuddy aggregates publicly available trial information.