Improving leg function in stroke survivors using exercise and electrical stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of combining low-intensity resistance training with blood flow restriction (LIRT-BFR) and transcutaneous electrical nerve stimulation (TENS) on leg function in individuals with chronic stroke. Participants will be randomly assigned to one of four groups to receive different combinations of LIRT, BFR, and TENS. The training will utilize 20% of each participant's maximum lifting capacity, with blood flow restriction applied through an automated pressure cuff during exercises. The goal is to evaluate improvements in lower extremity strength, mobility, and overall quality of life for stroke survivors.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Hong Kong Polytechnic University
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Shamay NG, PhD — The Hong Kong Polytechnic University
• Study coordinator: Shamay NG, PhD
• Email: shamay.ng@polyu.edu.hk
• Phone: +852 27664889

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.