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Completed

NCT Number: NCT07138118

Study of Blood Flow Restriction and Cognitive-Motor Dual Task Training to Improve Strength, Gait, and Balance in People With Subacute Stroke

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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahmyook University

Seoul, 01795, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Blood Flow Restriction + Dual Task Training

Behavioral

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.

Other names: BFR-DT, Individualized BFR

Dual Task Training Only

Behavioral

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.

Other names: Dual Task Gait Training, DT

Primary outcomes

  1. 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.

Secondary outcomes

  1. 10-Meter Walk Test (10MWT)

    Time frame: Baseline and after 5 weeks of intervention

    Walking speed (m/s) will be measured over a middle 10-meter segment of a 14-meter walking path. Higher values indicate better performance.

  2. Timed Up and Go Test (TUG)

    Time frame: Baseline and after 5 weeks of intervention

    Shorter completion time on the TUG indicates improved functional balance and mobility.

  3. Korean Version of Falls Efficacy Scale - International (KFES-I)

    Time frame: Baseline and after 5 weeks of intervention

    KFES-I assesses confidence in avoiding falls during daily activities. Lower scores indicate higher confidence.

  4. Functional Gait Assessment (FGA)

    Time frame: Baseline and after 5 weeks of intervention

    The FGA is a 10-item test that assesses postural stability during various walking tasks. Higher scores indicate better functional gait and balance.

Sponsors and collaborators

Lead sponsor

Sahmyook University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Dec 12, 2025

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.

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