RecruitingNot ApplicableNCT06838013

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

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

Sponsor

The Hong Kong Polytechnic University

Enrollment

92 participants

Start Date

Jun 17, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke

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.

Eligibility

Min Age: 50 YearsMax Age: 85 Years

Inclusion Criteria7

are between 50 and 85 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.

Exclusion Criteria8

have any additional medical, cardiovascular or orthopedic conditions that would hinder their treatment or assessment;
have a cardiac pacemaker;
have aphasia or cognitive difficulties that may interfere with their comprehension of instructions;
have had one or more epileptic seizures within the year prior to the date of inclusion in the study;
have an intracerebral metal clip;
have a major somatosensory deficit
have any contraindication to tDCS;
are currently involved in drug studies or other clinical trials.

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Interventions

DEVICETranscranial 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.

DEVICESham 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.

DEVICEBilateral 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.

DEVICEPlacebo 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.

BEHAVIORALLower-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.