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

NCT06838013 | Recruiting

• 1 other identifier: 2023_GRF_Ng
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

transcranial direct current stimulation; transcutaneous electric nerve stimulation; stroke; rehabilitation

Outcome Measures

Primary Outcomes (3)

• Paretic ankle dorsiflexor strength

  The paretic ankle dorsiflexor strength (in kilograms) is measured with a Nicholas hand-held dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) in supine lying position. The muscle strength will be measured twice. The average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle dorsiflexor strength.

  Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)

• Paretic ankle plantarflexor strength

  The paretic ankle plantarflexor strength (in kilograms) is measured with a Nicholas hand-held dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) in supine lying position. The muscle strength will be measured twice. The average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle dorsiflexor strength.

  Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)

• Fugl-Meyer Assessment of Lower Extremity (FMA-LE)

  FMA-LE is used to evaluate the lower extremity motor control, including reflexes, voluntary control of isolated movement and coordination. The scale score ranging from 0 to 34, with 17 items and ordinal scoring from 0 to 2. A higher score indicates a better lower extremity motor control.

  Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)

Secondary Outcomes (10)

• 10-Meter Walk Test (10MWT)

  Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)

• Timed 'Up and Go' test (TUG)

  Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)

• Lower-extremity motor co-ordination test

  Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)

• Gait Parameters (via GAITRite)

  Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)

• Berg Balance Scale (BBS)

  Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)

Study Arms (4)

Anodal tDCS+Bi-TENS

EXPERIMENTAL

All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks.

Device: Transcranial direct current stimulation (tDCS); Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS); Behavioral: Lower-limb task-oriented training

Sham-tDCS+Bi-TENS

SHAM COMPARATOR

All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks.

Device: Sham transcranial direct current stimulation (Sham-tDCS); Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS); Behavioral: Lower-limb task-oriented training

Anodal tDCS+placebo-TENS

PLACEBO COMPARATOR

All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks.

Control training

PLACEBO COMPARATOR

All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks.

Device: Sham transcranial direct current stimulation (Sham-tDCS); Device: Placebo transcutaneous electrical nerve stimulation (Placebo-TENS); Behavioral: Lower-limb task-oriented training

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

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.

Anodal tDCS+Bi-TENS

Sham transcranial direct current stimulation (Sham-tDCS) DEVICE

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.

Control training; Sham-tDCS+Bi-TENS

Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS) DEVICE

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.

Anodal tDCS+Bi-TENS; Sham-tDCS+Bi-TENS

Placebo transcutaneous electrical nerve stimulation (Placebo-TENS) DEVICE

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.

Control training

Lower-limb task-oriented training BEHAVIORAL

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.

Anodal tDCS+Bi-TENS; Control training; Sham-tDCS+Bi-TENS

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 an intracerebral metal clip;
• have a major somatosensory deficit
• have any contraindication to tDCS;
• are currently involved in drug studies or other clinical trials.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Shamay Ng, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shamay NG, PhD

CONTACT

+852 27664889; shamay.ng@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: June 17, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)