Subacute StrokeNCT07138118
Study of Blood Flow Restriction and Cognitive-Motor Dual Task Training to Improve Strength, Gait, and Balance in People With Subacute Stroke
A study testing Blood Flow Restriction + Dual Task Training and Dual Task Training Only in people with Subacute Stroke, run by Sahmyook University at 1 site in South Korea.
Trial summary
This study aims to evaluate the effects of individualized blood flow restriction (BFR) training combined with cognitive-motor dual task intervention on lower limb muscle strength, gait ability, and fall stability in patients with subacute stroke. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Subacute Stroke
- What is being tested?
- Blood Flow Restriction + Dual Task Training and Dual Task Training Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Sep 2025to 11 Nov 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with subacute stroke within 1 to 6 months after onset
- Able to walk at least 10 meters, with or without assistive devices
- Modified Ashworth Scale score less than 1
- Korean Mini-Mental State Examination (K-MMSE) score of 24 or higher
Who cannot join
- History of psychiatric disorders or cognitive impairment
- Presence of peripheral neuropathy
- Resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite medication
- Diagnosis of heart failure or unstable angina
- History of bypass surgery within the past 3 months
- Serious musculoskeletal disorders affecting gait (e.g., amputation, fracture)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Individualized Blood Flow Restriction Training Combined With a Cognitive-Motor Dual Task Intervention on Lower Limb Strength, Gait Ability, and Fall Stability in Subacute Stroke Patients: A Randomized Controlled Trial
This study aims to evaluate the effects of individualized blood flow restriction (BFR) training combined with cognitive-motor dual task intervention on lower limb muscle strength, gait ability, and fall stability in patients with subacute stroke. A total of 28 participants will be randomly assigned to either the experimental group (BFR + dual task training) or the control group (dual task only). The intervention will last for 5 weeks, with training sessions conducted three times per week, each lasting 40 minutes. The primary outcome is lower limb strength measured by the Five Times Sit-to-Stand Test. Secondary outcomes include gait ability (10-Meter Walk Test and Functional Gait Assessment) and fall stability (Timed Up and Go Test and Korean version of the Falls Efficacy Scale-International). This study seeks to verify whether combining low-pressure BFR training (40% of arterial occlusion pressure) with dual task training can be a clinically effective strategy for improving motor and cognitive function in individuals with subacute stroke.
Read the detailed description
Subacute stroke is defined as the period between 7 days and 6 months after stroke onset, a critical window during which neuroplasticity and functional recovery are highly active. During this phase, individualized and task-specific interventions can enhance motor recovery. Blood flow restriction (BFR) training is a promising low-load exercise modality that induces physiological effects similar to high-intensity training by restricting venous return using a proximal cuff. Studies suggest that BFR training at 40% of arterial occlusion pressure (AOP) can safely stimulate muscle hypertrophy and strength, particularly in populations with limited exercise capacity, such as stroke survivors.
Additionally, dual task training, which combines motor and cognitive tasks, has been shown to improve executive function and gait performance by increasing prefrontal cortex activity. While each approach has independent benefits, the combination of peripheral muscle activation through BFR and central stimulation via cognitive-motor dual tasks may provide synergistic effects on functional recovery.
This randomized controlled trial will compare an intervention group receiving BFR training (40% AOP) with concurrent dual task gait training to a control group performing the same cognitive-motor dual tasks without BFR. Both groups will train three times per week for 5 weeks. Outcome measures will assess changes in lower limb strength, gait ability, and fall stability before and after the intervention. The study also addresses safety and standardization concerns in BFR application by using pulse oximeter-based AOP measurement protocols.
By providing evidence on the efficacy and safety of combining BFR and dual-task training in subacute stroke rehabilitation, this study aims to contribute to the development of individualized, clinically applicable intervention strategies.
- Conditions
- Subacute Stroke
- Being tested
- Blood Flow Restriction + Dual Task Training, Dual Task Training Only
- Keywords
- Subacute Stroke, BFR, Dual Task Training, Gait, Balance, Muscle Strength, Falls Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction + Dual Task TrainingBehavioural
Also called BFR-DT, Individualized BFR
Participants will undergo lower limb resistance and gait training while wearing blood flow restriction cuffs at 40% of their individualized arterial occlusion pressure. Tasks include walking, sit-to-stand, and obstacle crossing combined with verbal fluency or serial subtraction. Training is performed 3 times per week for 5 weeks.
Dual Task Training OnlyBehavioural
Also called Dual Task Gait Training, DT
Participants will perform the same cognitive-motor dual task training without blood flow restriction. Tasks include forward walking, obstacle crossing, and sit-to-stand exercises with concurrent cognitive tasks such as verbal fluency or serial subtraction. Training is performed 3 times per week for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: BFR + Dual Task | Experimental | Participants in this group will perform cognitive-motor dual task training while wearing blood flow restriction (BFR) cuffs set at 40% of their individualized arterial occlusion pressure (AOP). The training consists of three sessions per week for five weeks. Each session lasts 40 minutes and includes tasks such as forward walking, obstacle crossing, and seated-to-stand with concurrent verbal fluency or serial subtraction tasks. Receives: Behavioral: Blood Flow Restriction + Dual Task Training |
| Active Comparator: Dual Task Only | Active comparator | Participants in this group will perform the same cognitive-motor dual task training as the experimental group but without blood flow restriction. The training will also be conducted three times per week for five weeks, with each session lasting 40 minutes. Tasks include walking and obstacle navigation combined with verbal fluency or serial subtraction exercises. Receives: Behavioral: Dual Task Training Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 Times Sit-to-Stand Test (5STS)
Lower limb strength will be assessed using the Five Times Sit-to-Stand Test. A shorter time indicates better performance.
Measured: Baseline and after 5 weeks of intervention
Secondary outcomes (4)
10-Meter Walk Test (10MWT)
Walking speed (m/s) will be measured over a middle 10-meter segment of a 14-meter walking path. Higher values indicate better performance.
Measured: Baseline and after 5 weeks of intervention
Timed Up and Go Test (TUG)
Shorter completion time on the TUG indicates improved functional balance and mobility.
Measured: Baseline and after 5 weeks of intervention
Korean Version of Falls Efficacy Scale - International (KFES-I)
KFES-I assesses confidence in avoiding falls during daily activities. Lower scores indicate higher confidence.
Measured: Baseline and after 5 weeks of intervention
Functional Gait Assessment (FGA)
The FGA is a 10-item test that assesses postural stability during various walking tasks. Higher scores indicate better functional gait and balance.
Measured: Baseline and after 5 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start8 Sep 2025
- Primary completion17 Oct 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subacute StrokeStudies 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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seonghwan Kim, Sahmyook University
- Investigators
- Seungwon Lee, PhD, Principal investigator, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138118
- Sponsor's protocol ID
- SYU 2025-06-027-001
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu YC, Yang YR, Tsai YA, Wang RY. Cognitive and motor dual task gait training improve dual task gait performance after stroke - A randomized controlled pilot trial. Sci Rep. 2017 Jun 22;7(1):4070. doi: 10.1038/s41598-017-04165-y.
PubMed 28642466Ahmed I, Mustafaoglu R, Erhan B. The effects of low-intensity resistance training with blood flow restriction versus traditional resistance exercise on lower extremity muscle strength and motor functionin ischemic stroke survivors: a randomized controlled trial. Top Stroke Rehabil. 2024 May;31(4):418-429. doi: 10.1080/10749357.2023.2259170. Epub 2023 Sep 19.
PubMed 37724785
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Individualized Blood Flow Restriction Training Combined With a Cognitive-Motor Dual Task Intervention on Lower Limb Strength, Gait Ability, and Fall Stability in Subacute Stroke Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07138118
- Acronym / sponsor ID
- SYU 2025-06-027-001
- Conditions
- Subacute Stroke
- Keywords
- Subacute Stroke, BFR, Dual Task Training, Gait, Balance, Muscle Strength, Falls Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 22 Aug 2025 (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.
This study aims to evaluate the effects of individualized blood flow restriction (BFR) training combined with cognitive-motor dual task intervention on lower limb muscle strength, gait ability, and fall stability in patients with subacute stroke. A total of 28 participants will be randomly assigned to either the experimental group (BFR + dual task training) or the control group (dual task only). The intervention will last for 5 weeks, with training sessions conducted three times per week, each lasting 40 minutes. The primary outcome is lower limb strength measured by the Five Times Sit-to-Stand Test. Secondary outcomes include gait ability (10-Meter Walk Test and Functional Gait Assessment) and fall stability (Timed Up and Go Test and Korean version of the Falls Efficacy Scale-International). This study seeks to verify whether combining low-pressure BFR training (40% of arterial occlusion pressure) with dual task training can be a clinically effective strategy for improving motor and cognitive function in individuals with subacute stroke.
Detailed description
Subacute stroke is defined as the period between 7 days and 6 months after stroke onset, a critical window during which neuroplasticity and functional recovery are highly active. During this phase, individualized and task-specific interventions can enhance motor recovery. Blood flow restriction (BFR) training is a promising low-load exercise modality that induces physiological effects similar to high-intensity training by restricting venous return using a proximal cuff. Studies suggest that BFR training at 40% of arterial occlusion pressure (AOP) can safely stimulate muscle hypertrophy and strength, particularly in populations with limited exercise capacity, such as stroke survivors.
Additionally, dual task training, which combines motor and cognitive tasks, has been shown to improve executive function and gait performance by increasing prefrontal cortex activity. While each approach has independent benefits, the combination of peripheral muscle activation through BFR and central stimulation via cognitive-motor dual tasks may provide synergistic effects on functional recovery.
This randomized controlled trial will compare an intervention group receiving BFR training (40% AOP) with concurrent dual task gait training to a control group performing the same cognitive-motor dual tasks without BFR. Both groups will train three times per week for 5 weeks. Outcome measures will assess changes in lower limb strength, gait ability, and fall stability before and after the intervention. The study also addresses safety and standardization concerns in BFR application by using pulse oximeter-based AOP measurement protocols.
By providing evidence on the efficacy and safety of combining BFR and dual-task training in subacute stroke rehabilitation, this study aims to contribute to the development of individualized, clinically applicable intervention strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: BFR + Dual Task | Experimental | Behavioral: Blood Flow Restriction + Dual Task TrainingParticipants in this group will perform cognitive-motor dual task training while wearing blood flow restriction (BFR) cuffs set at 40% of their individualized arterial occlusion pressure (AOP). The training consists of three sessions per week for five weeks. Each session lasts 40 minutes and includes tasks such as forward walking, obstacle crossing, and seated-to-stand with concurrent verbal fluency or serial subtraction tasks. |
| Active Comparator: Dual Task Only | Active comparator | Behavioral: Dual Task Training OnlyParticipants in this group will perform the same cognitive-motor dual task training as the experimental group but without blood flow restriction. The training will also be conducted three times per week for five weeks, with each session lasting 40 minutes. Tasks include walking and obstacle navigation combined with verbal fluency or serial subtraction exercises. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with subacute stroke within 1 to 6 months after onset
- Able to walk at least 10 meters, with or without assistive devices
- Modified Ashworth Scale score less than 1
- Korean Mini-Mental State Examination (K-MMSE) score of 24 or higher
Key exclusion criteria (6 listed)
- History of psychiatric disorders or cognitive impairment
- Presence of peripheral neuropathy
- Resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite medication
- Diagnosis of heart failure or unstable angina
- History of bypass surgery within the past 3 months
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 |
|---|---|---|
| Blood Flow Restriction + Dual Task TrainingAlso: BFR-DT, Individualized BFRParticipants will undergo lower limb resistance and gait training while wearing blood flow restriction cuffs at 40% of their individualized arterial occlusion pressure. Tasks include walking, sit-to-stand, and obstacle crossing combined with verbal fluency or serial subtraction. Training is performed 3 times per week for 5 weeks. | Behavioural | Experimental: BFR + Dual Task |
| Dual Task Training OnlyAlso: Dual Task Gait Training, DTParticipants will perform the same cognitive-motor dual task training without blood flow restriction. Tasks include forward walking, obstacle crossing, and sit-to-stand exercises with concurrent cognitive tasks such as verbal fluency or serial subtraction. Training is performed 3 times per week for 5 weeks. | Behavioural | Active Comparator: Dual Task Only |
Primary outcome
5 Times Sit-to-Stand Test (5STS)
Time frame: Baseline and after 5 weeks of intervention
Lower limb strength will be assessed using the Five Times Sit-to-Stand Test. A shorter time indicates better performance.
4 secondary outcomes
10-Meter Walk Test (10MWT)
Time frame: Baseline and after 5 weeks of intervention
Timed Up and Go Test (TUG)
Time frame: Baseline and after 5 weeks of intervention
Korean Version of Falls Efficacy Scale - International (KFES-I)
Time frame: Baseline and after 5 weeks of intervention
Functional Gait Assessment (FGA)
Time frame: Baseline and after 5 weeks of intervention
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 12 Dec 2025.
- Results publication: PubMed 28642466Liu YC, Yang YR, Tsai YA, Wang RY. Cognitive and motor dual task gait training improve dual task gait performance after stroke - A randomized controlled pilot trial. Sci Rep. 2017 Jun 22;7(1):4070. doi: 10.1038/s41598-017-04165-y.
- Results publication: PubMed 37724785Ahmed I, Mustafaoglu R, Erhan B. The effects of low-intensity resistance training with blood flow restriction versus traditional resistance exercise on lower extremity muscle strength and motor functionin ischemic stroke survivors: a randomized controlled trial. Top Stroke Rehabil. 2024 May;31(4):418-429. doi: 10.1080/10749357.2023.2259170. Epub 2023 Sep 19.
- Individual participant dataSharing planned: No
Related trials for Subacute Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
Stroke
Active, not recruiting
Comparative Effects of Sensorimotor Training and tACS on Upper Limb Function and Cervical Proprioception in Subacute Stroke
Sub-acute Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Seungwon Lee, PhD principal investigator
Sahmyook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction + Dual Task Training and Dual Task Training Only in people with Subacute Stroke, run by Sahmyook University at 1 site in South Korea.
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 4 inclusion and 6 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 12 Dec 2025. 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 South Korea. 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?
5 Times Sit-to-Stand Test (5STS) (time frame: Baseline and after 5 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07138118, which also lists 2 linked publications.
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 12 Dec 2025.