NCT06973590 Blood Flow Restriction and Transcutaneous Electrical Nerve Stimulation on Motor Function in Stroke
| NCT ID | NCT06973590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Chronic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. are between 50 and 80 years of age; 2. have had a single stroke more than 6 months and less than 15 years; 3. have at least 5 degrees of active ankle dorsiflexion in the antigravity position; 4. are able to walk 10 m independently, with or without a walking aid; 5. are able to score 6 or higher out of 10 on the abbreviated mental test; 6. have no skin allergies (e.g. redness or itchiness after application of the electrical stimulation pads) to electrical stimulation or electrodes; 7. are able to follow instructions and give informed consent. Exclusion Criteria: 1. presence of other comorbidities like varicose veins, peripheral neuropathy, cancer, musculoskeletal injury, lower limb peripheral edema, post-surgical swelling, open wounds, or on a medication that increases blood clotting risk; 2. resting blood pressure ≥ 160/100 mmHg even after taking medications, cardiovascular comorbidity, heart failure, unstable angina, by-pass surgery, a pacemaker; 3. administration of botulinum toxin in the lower limb at least 6 months prior to training; 4. history of epilepsy, cochlear implants, any type of deep brain stimulator and metal implants in the head or neck; 5. currently not participating in resistance training or high-intensity or long duration cardiovascular exercise; 6. lack the ability to feel pain (because of paralysis), or other subjects who cannot complain of discomfort.
Contact & Investigator
Shamay NG, PhD
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT06973590 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Chronic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06973590 currently recruiting?
Yes, NCT06973590 is actively recruiting participants. Contact the research team at shamay.ng@polyu.edu.hk for enrollment information.
Where is the NCT06973590 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06973590 clinical trial?
NCT06973590 is sponsored by The Hong Kong Polytechnic University. The principal investigator is Shamay NG, PhD at The Hong Kong Polytechnic University. The trial plans to enroll 60 participants.
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