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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 5 Times Sit-to-Stand Test (5STS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Experimental: BFR + Dual Task
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.
干预措施: Blood Flow Restriction + Dual Task Training (Behavioral)
Active Comparator: Dual Task Only
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.
干预措施: Dual Task Training Only (Behavioral)
结局指标
主要结局
5 Times Sit-to-Stand Test (5STS)
时间窗: 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.
次要结局
- Functional Gait Assessment (FGA)(Baseline and after 5 weeks of intervention)
- Korean Version of Falls Efficacy Scale - International (KFES-I)(Baseline and after 5 weeks of intervention)
- 10-Meter Walk Test (10MWT)(Baseline and after 5 weeks of intervention)
- Timed Up and Go Test (TUG)(Baseline and after 5 weeks of intervention)
研究者
Seonghwan Kim
Principal Investigator, MSc Candidate, Department of Physical Therapy, Sahmyook University
Sahmyook University