Improving leg function in stroke survivors using exercise and electrical stimulation

Effects of Low-intensity Resistance Training With Blood Flow Restriction and Transcutaneous Electrical Nerve Stimulation on Lower Limb Motor Function in People With Stroke

This study is testing if a mix of light weight training and electrical stimulation can help stroke survivors improve their leg strength and mobility.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: The Hong Kong Polytechnic University (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06973590 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 to 80 who have experienced a single stroke more than 6 months and less than 15 years ago and can walk independently.

Not a fit: Patients with significant comorbidities or contraindications to exercise or electrical stimulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance mobility and quality of life for stroke survivors.

How similar studies have performed: While the combination of these specific interventions in stroke rehabilitation is relatively novel, similar approaches have shown promise in other populations.

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.

Where this trial is running

Hong Kong

• 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

Conditions Chronic Stroke; blood flow restriction; transcutaneous electrical nerve stimulation; stroke; low-intensity resistance training