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

NCT07138118 | Completed

• 1 other identifier: SYU 2025-06-027-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Subacute Stroke

Keywords

Subacute Stroke; BFR; Dual Task Training; Gait; Balance; Muscle Strength; Falls Efficacy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after 5 weeks of intervention

Secondary Outcomes (4)

• 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

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

  Baseline and after 5 weeks of intervention

• Functional Gait Assessment (FGA)

  Baseline and after 5 weeks of intervention

Study Arms (2)

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.

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.

Behavioral: Dual Task Training Only

Interventions

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.

Also known as: BFR-DT, Individualized BFR

Experimental: BFR + Dual Task

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.

Also known as: Dual Task Gait Training, DT

Active Comparator: Dual Task Only

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

Sahmyook University

Seoul, Seoul, 01795, South Korea

Location

Related Publications (2)

• 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.

  PMID: 28642466 RESULT

• Ahmed 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.

  PMID: 37724785 RESULT

Study Officials

• Seungwon Lee, PhD

  Sahmyook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MSc Candidate, Department of Physical Therapy, Sahmyook University

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: September 8, 2025
• Primary Completion: October 17, 2025
• Study Completion: November 11, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)