Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
NCT06973590

Blood Flow Restriction and Transcutaneous Electrical Nerve Stimulation on Motor Function in Stroke

Led by The Hong Kong Polytechnic University · Updated on 2025-05-15

80

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Stroke commonly results in persistent leg impairments that limit mobility and reduce quality of life. This study investigates whether combining low-intensity resistance training with blood flow restriction (LIRT-BFR) and transcutaneous electrical nerve stimulation (TENS) can effectively improve leg function in stroke survivors. Participants with chronic stroke will be randomly assigned to one of four intervention groups: 1) LIRT with simulated BFR and simulated TENS; 2) LIRT with actual BFR and simulated TENS; 3) LIRT with simulated BFR and actual TENS; 4) LIRT with both actual BFR and actual TENS. The resistance training utilizes 20% of each participant's maximum lifting capacity. For blood flow restriction, an automated pressure cuff (SmartCuffs 4.0) will be placed on the upper portion of the affected leg, inflated to 50% of the individual's occlusion pressure during exercises and deflated during rest periods. TENS therapy delivers controlled electrical impulses through electrodes positioned on the anterior thigh. Each 60-minute session includes a 10-minute warm-up followed by 40 minutes of targeted resistance exercises (leg extensions, leg presses, and weight-bearing squats) and concludes with 10 minutes of stationary cycling. The resistance protocol involves 3 sets of 20 repetitions with standardized rest intervals between sets and exercises. Participants will attend three sessions weekly for six weeks. Assessments will be conducted at baseline, midpoint (3 weeks), completion (6 weeks), and follow-up (1 month post-intervention). The primary outcome measure is the Fugl-Meyer Assessment for Lower Extremity function, with secondary measures including muscle strength, stiffness, balance, mobility, walking capacity, and gait parameters. To understand the underlying mechanisms, we will measure muscle oxygenation using near-infrared spectroscopy, evaluate muscle structure via ultrasound, and monitor physiological responses including heart rate variability and perceived exertion for safety monitoring.

CONDITIONS

Official Title

Blood Flow Restriction and Transcutaneous Electrical Nerve Stimulation on Motor Function in Stroke

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 50 and 80 years
  • Single stroke occurred more than 6 months and less than 15 years ago
  • At least 5 degrees of active ankle dorsiflexion in the antigravity position
  • Able to walk 10 meters independently, with or without a walking aid
  • Score of 6 or higher out of 10 on the abbreviated mental test
  • No skin allergies or reactions to electrical stimulation or electrodes
  • Able to follow instructions and provide informed consent
Not Eligible

You will not qualify if you...

  • Presence of other conditions like varicose veins, peripheral neuropathy, cancer, musculoskeletal injury, lower limb swelling, post-surgical swelling, open wounds, or use of blood clotting medications
  • Resting blood pressure equal to or above 160/100 mmHg despite medication, cardiovascular issues, heart failure, unstable angina, bypass surgery, or pacemaker
  • Received botulinum toxin in the lower limb within 6 months before training
  • History of epilepsy, cochlear implants, deep brain stimulators, or metal implants in the head or neck
  • Not currently doing resistance training or high-intensity or long-duration cardiovascular exercise
  • Lack the ability to feel pain or cannot report discomfort due to paralysis

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Trial Site Locations

Total: 1 location

1

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

S

Shamay NG, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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