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

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Chronic Stroke
Interventions
DEVICE

Blood flow restriction (BFR)

BFR implementation involves an automated restriction band (SmartCuffs 4.0) positioned at the proximal region of the affected lower extremity, calibrated to 50% of the individual's lower limb occlusion pressure (LOP). The pressure system remains inflated throughout active training phases and is systematically deflated during inter-exercise intervals.

DEVICE

Transcutaneous electrical nerve stimulation (TENS)

TENS will be delivered to the anterior thigh region of the paretic leg using a 120z Dual-Channel TENS Unit (ITO Physiotherapy \& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching.

DEVICE

Sham blood flow restriction (Sham-BFR)

Sham BFR implementation involves an automated restriction band (SmartCuffs 4.0) positioned at the proximal region of the affected lower extremity, calibrated to 50% of the individual's lower limb occlusion pressure (LOP). But the pressure system remains deflated throughout active training and resting phases.

DEVICE

Sham transcutaneous electrical nerve stimulation (Sham-TENS)

Sham TENS will be delivered to the anterior thigh region of the paretic leg using a 120z Dual-Channel TENS Unit (ITO Physiotherapy \& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching. But the stimulator will only be applied for the first and last 30 seconds.

BEHAVIORAL

Low-intensity resistance training (LIRT)

The LIRT protocol utilizes 20% of one-repetition maximum (1-RM) as the standardized training load. LIRT including leg extensions, leg presses, and load-bearing squats focused on the affected limb. Each resistance exercise consists of 3 sets of 20 repetitions with rest intervals.

Trial Locations (1)

Unknown

RECRUITING

The Hong Kong Polytechnic University, Hong Kong

All Listed Sponsors
lead

The Hong Kong Polytechnic University

OTHER