An interventional study of BFR in Cerebro-vascular Accident, Exercise and Blood Flow Restriction (BFR) Training Effects, sponsored by Saint Joseph's University, Philadelphia. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Saint Joseph's University, Philadelphia · Not applicable, Interventional, and Treatment
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.
Individuals with strokes live with nerve damage or loss, which can result in muscle atrophy, a loss in muscle strength, and size. There is a functional loss of the upper extremity in this population, which can reduce their independence with activities of daily living, resulting in their reliance on friends, family, or caregivers. Blood flow restriction (BFR) training is gaining attention in the neurological population as a rehabilitation intervention. BFR training involves a specialized cuff that is applied proximally to the injured limb to occlude arterial blood flow by approximately 40-80%. 3 The goal of BFR training is to increase muscle size and strength without using high-load intervention, which may be found difficult or unsafe for the stroke population.
This topic is important because BFR can serve as a potential rehabilitation modality that can be paired with exercise for individuals with neurological impairments. They could benefit from a low-intensity exercise program that aids in muscle hypertrophy and increases in strength without putting the individual through the additional stress of high-intensity exercises. Adversely, it has to be assessed that repeated exposure of BFR could cause dampening of perceptual responses as well as discomfort. It is essential to determine the potential long-term benefits to dictate if this treatment regime is effective and safe for the neurological population.
There is ample research about BFR training in its effectiveness for muscle hypertrophy and strength in the arm as well as its variability in exercises that can be utilized. There are other outcomes that can be assessed as well, including discomfort, pain, and perceived exertion. Previous research has demonstrated that muscles respond to overload stresses with an increase in the size of muscle fibers and the ability to generate a greater force capacity. Blood flow restriction training is shown to be effective in increasing muscle size and strength using lower loads for both untrained and trained individuals. Moore et al. discuss that while BFR training increases muscle size and strength, the mechanisms behind this remain unclear, and little evidence assesses the contribution to neuromuscular adaptation to these gains.
There is a knowledge gap involving the optimal training protocol for the neurological population. There is little research and evidence that compares low-load BFR training and traditional strength training in the neurological population. The primary aim of this study is to determine if the implementation of blood flow restriction therapy in individuals post-CVA will demonstrate improvements in upper extremity function. The secondary aim is to investigate the efficacy in utilizing BFR to promote significant improvements in a subject's dominant or non-dominant upper extremity.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 16 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Saint Joseph's University, Philadelphia is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Compared within Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria: Between the ages of 18 and 65;
Exclusion Criteria:
BFR will be applied to the involved upper extremity of each participant at the end of each session. The protocol for BFR in the UE is as follows: 1) Blood pressure in the bilateral upper extremities will be obtained. 2) The BFR cuff will be placed on the predetermined UE. 3) A Doppler device within the BFR cuff will calculate the total limb occlusion pressure for the subject's involved upper extremity. 4) The subjects had 50% arterial occlusion pressure applied throughout shoulder abduction strengthening (at the recommended threshold). 5) The BFR cuff will be left on the participant involved's arm for up to 8 minutes as he/she completes a functional activity circuit with the use of the restricted upper extremity. 6) RPE measurements will be taken pre-intervention, periodically during intervention every 3 minutes, and post-intervention.
Behavioral: BFR
BFR will be applied to the involved upper extremity of each participant at the end of each session. The protocol for BFR in the UE is as follows: 1) Blood pressure in the bilateral upper extremities will be obtained. 2) The BFR cuff will be placed on the predetermined UE. 3) A doppler device within the BFR cuff will calculate the total limb occlusion pressure for the subject's involved upper extremity. The subjects had 30% arterial occlusion pressure applied during strength training (below the recommended threshold). 5) The BFR cuff will be left on the participant involved's arm for up to 8 minutes as he/she completes a functional activity circuit with the use of the restricted upper extremity. 6) RPE measurements will be taken pre-intervention, periodically during intervention every 3 minutes, and post-intervention.
Behavioral: BFR
Sessions began with an upper extremity circuit consisting of functional and neuromuscular re-education exercises, switching between proximal and distal joints for a total of 200+ repetitions. Upon completion of the circuit, a BFR device was applied for approximately 8 minutes as the participant engaged in strength training exercises for a total of 75 repetitions. 30-second rest periods were given after the first 30 repetitions and then following each set of 15 repetitions. In summary, each participant completed eight circuits over a one-hour period or continued until 200+ UE repetitions were achieved, followed by 75 repetitions of strengthening exercises. BFR will be applied to the involved upper extremity of each participant at the end of each session.
Wearable Accelerometry
The parameters extracted from the accelerometry data consist of upper limb use, bilateral magnitude, use ratio, and magnitude ratio. The upper limb use denotes the duration (in hours) they used their involved arm. Bilateral magnitude measures the intensity of movement in bilateral UEs on a scale of 0-300, indicating minimal to maximal intensity. Use a ratio to compare the usage of the involved vs. involved UE in terms of overall movement throughout the designated time period. Magnitude ratio compares both intensity and amount of use between the involved and uninvolved UE, using a scale of -7 to 7. A leftward shift, or grade below 0, signifies more use of the uninvolved UE. A rightward shift, or grade above 0, indicates increased use of the involved UE.
Time frame: Subjects wear the wrist accelerometers up to 3 days from enrollment prior to training, for a 3-day period, and up to 3 days post-training for a 3-day period
Upper Extremity Fugl-Meyer (UE FMA) for upper extremity impairment measure
A measure of impairment measuring changes in upper extremity movement and motor control (ranging from 0 to 66, with a higher score a better outcome)
Time frame: Data collected up to 3 days prior to training and then up to 3 days post-training
Wolf Motor Function Test (WMFT) for upper extremity function
The Wolf Motor Function Test is an activity measure that assesses the UE motor function through the use of timed and functional tasks performed at each joint. Several tasks are performed utilizing the parameters of as many repetitions as possible or within 120 seconds. Tasks included in the WMFT are performed from the most proximal to the most distal joints of the bilateral upper extremity (BUE), revealing motor deficits present between the uninvolved and involved UE. Lower time equals a better outcome, but the movement quality is scored 0-5, with 5 being a better outcome.
Time frame: Data collected up to 3 days prior to training initiation and then up to 3 days post training completion
Stroke Impact Scale participation measure
The SIS is a patient-reported outcome measure and was used to quantify the patient's perception of their baseline function as well as overall strength and mobility and to identify changes in this following treatment. This outcome measure assessed the subjects' perception of their own strength, hand function, activities of daily living, mobility, communication, emotion, memory \& thinking, and participation. Each category was scored between 0 and 100, with higher scores indicating greater patient-perceived function.
Time frame: Data collected up to 3 days prior to training initiation and then up to 3 days post training completion
Plan to share: Yes — The descriptive statistics, as well as the results of the outcome measures, will be shared as public data for the purposes of improving the larger database sets, such as the ENIGMA stroke studies trial.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: July 1, 2026 and shared indefinitely
Access criteria: I will have to share the data with the researchers upon request, outside of the ENIGMA group, where my data will be sent to them once it is analyzed completely. Typically the ENIGMA group wants the FMA data, but will share all with them if interested.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Saint Joseph's University, Philadelphia