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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• are between 50 and 80 years of age;

• have had a single stroke more than 6 months and less than 15 years;

• have at least 5 degrees of active ankle dorsiflexion in the antigravity position;

• are able to walk 10 m independently, with or without a walking aid;

• are able to score 6 or higher out of 10 on the abbreviated mental test;

• have no skin allergies (e.g. redness or itchiness after application of the electrical stimulation pads) to electrical stimulation or electrodes;

• are able to follow instructions and give informed consent.

Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Shamay NG, PhD
shamay.ng@polyu.edu.hk
+852 27664889
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 80
Treatments
Experimental: LIRT + BFR + TENS
All subjects will receive 60-minute sessions of LIRT with both actual BFR and actual TENS intervention, 3 sessions per week for 6 weeks.
Sham_comparator: LIRT + sham BFR + TENS
All subjects will receive 60-minute sessions of LIRT with simulated BFR and actual TENS, 3 sessions per week for 6 weeks.
Sham_comparator: LIRT + BFR + sham TENS
All subjects will receive 60-minute sessions of LIRT with actual BFR and simulated TENS, 3 sessions per week for 6 weeks.
Placebo_comparator: LIRT + sham BFR + sham TENS
All subjects will receive 60-minute sessions of LIRT with simulated BFR and simulated TENS, 3 sessions per week for 6 weeks.
Related Therapeutic Areas
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov