Cerebro-vascular AccidentNCT07910734
Supplemental Blood Flow Restriction Training to Improve the Upper Extremity in Chronic Stroke
A study testing BFR in people with Cerebro-vascular Accident and Exercise, run by Saint Joseph's University, Philadelphia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cerebro-vascular Accident, Exercise, Blood Flow Restriction (BFR) Training Effects
- What is being tested?
- BFR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplemental Blood Flow Restriction Training to Improve Training of the Upper Extremity in Chronic Stroke: A Pilot Study
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.
Read the detailed description
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.
- Being tested
- BFR
- Keywords
- stroke, exercise, blood flow restriction, upper extremity
- Medical subject headings
- Motor Activity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFRBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BFR full dose | Experimental | 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. Receives: Behavioral: BFR |
| Sub threshold BFR | Active comparator | 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. Receives: Behavioral: BFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: Data collected up to 3 days prior to training initiation and then up to 3 days post training completion
Secondary outcomes (1)
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.
Measured: Data collected up to 3 days prior to training initiation and then up to 3 days post training completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Jan 2022
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebro-vascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be run in 2 groups consisting of an experimental group and a control group. The control group will perform the same interventions without a blood-flow restriction tourniquet system. A total of eight weeks will be allocated per each group to allow ample time to collect pre-test and post-test data in addition to completing the six-week training program.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Joseph's University, Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910734
- Sponsor's protocol ID
- 1475458
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Blood Flow Restriction Training to Improve Training of the Upper Extremity in Chronic Stroke: A Pilot Study
- ClinicalTrials.gov ID
- NCT07910734
- Acronym / sponsor ID
- 1475458
- Keywords
- stroke, exercise, blood flow restriction, upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Saint Joseph's University, PhiladelphiaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be run in 2 groups consisting of an experimental group and a control group. The control group will perform the same interventions without a blood-flow restriction tourniquet system. A total of eight weeks will be allocated per each group to allow ample time to collect pre-test and post-test data in addition to completing the six-week training program.
| Arm | Type | Receives |
|---|---|---|
| BFR full dose | Experimental | Behavioral: BFRBFR 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. |
| Sub threshold BFR | Active comparator | Behavioral: BFRBFR 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFRSessions 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. | Behavioural | BFR full dose, Sub threshold BFR |
Primary outcome
Wearable Accelerometry
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
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.
Upper Extremity Fugl-Meyer (UE FMA) for upper extremity impairment measure
Time frame: Data collected up to 3 days prior to training and then up to 3 days post-training
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)
Wolf Motor Function Test (WMFT) for upper extremity function
Time frame: Data collected up to 3 days prior to training initiation and then up to 3 days post training completion
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.
1 secondary outcome
Stroke Impact Scale participation measure
Time frame: Data collected up to 3 days prior to training initiation and then up to 3 days post training completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR in people with Cerebro-vascular Accident and Exercise, run by Saint Joseph's University, Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wearable Accelerometry (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.