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

RecruitingNAAges 50 Years - 80 YearsAllThe Hong Kong Polytechnic University
NCT06973590 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 def

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📋 Eligibility rules (as published)
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.
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What it tests

  • Blood flow restriction (BFR)
  • Transcutaneous electrical nerve stimulation (TENS)
  • Sham blood flow restriction (Sham-BFR)
  • Sham transcutaneous electrical nerve stimulation (Sham-TENS)
  • Low-intensity resistance training (LIRT)
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Where

1 site
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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