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RECRUITING
NCT06838013
NA

Effect of Combining Central and Peripheral Cutaneous Electrical Stimulation on Lower Limb Motor Function in People With Stroke

Sponsor: The Hong Kong Polytechnic University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. It is hypothesize that lower limb motor function can be best improved by combining anodal tDCS with TENS, when compared with sham-tDCS with TENS, anodal tDCS with placebo-TENS, or control training at improving ankle muscle strength, motor control of lower limbs, walking performance, functional mobility and community integration in people with stroke.

Official title: A Randomized Controlled Trial of Anodal Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation for Improving Lower Limb Function in Stroke Patients

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2024-06-17

Completion Date

2026-08-31

Last Updated

2025-07-09

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Transcranial direct current stimulation (tDCS)

tDCS will be delivered by a constant-current electrical stimulator (DC-stimulator; Eldith, Ilmenau, Germany). Rectangular electrodes covered with a saline-soaked sponge will be used for the anode and cathode. The anode will be placed over the leg area of the motor cortex, on the lesioned side, with the medial border of the electrode placed laterally to Cz on the international electroencephalogram 10-20 system. The cathode will be placed above the contralateral orbit. The stimulation intensity will be set at 2 mA for 30 minutes.

DEVICE

Sham transcranial direct current stimulation (Sham-tDCS)

Sham tDCS will be delivered by a constant-current electrical stimulator (DC-stimulator; Eldith, Ilmenau, Germany). Rectangular electrodes covered with a saline-soaked sponge will be used for the anode and cathode. The anode will be placed over the leg area of the motor cortex, on the lesioned side, with the medial border of the electrode placed laterally to Cz on the international electroencephalogram 10-20 system. The cathode will be placed above the contralateral orbit. The stimulation intensity will The stimulator will only be applied for the first and last 30 seconds.

DEVICE

Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)

TENS will be delivered to the common peroneal nerve of both intact and paretic leg for 30 minutes 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

Placebo transcutaneous electrical nerve stimulation (Placebo-TENS)

Placebo-TENS will be applied to identical-looking TENS devices, with the electrical circuit disconnected inside the devices. Placebo-TENS will be delivered to the common peroneal nerve of both intact and paretic leg for 30 minutes that set at 100 Hz, with 0.2 ms square pulses.

BEHAVIORAL

Lower-limb task-oriented training

The lower-limb task-oriented training comprises 5 exercises for 30 minutes, namely stepping up and down, heel lift a dorsiflexed position, partial squatting, gait re-education and transition training.

Locations (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong