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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorThe Hong Kong Polytechnic University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

92 Participants
are divided into 4 treatment groups
Group A: Anodal tDCS+Bi-TENSExperimental treatment 3 interventions
Group B: Sham-tDCS+Bi-TENSSham comparator 3 interventions
Group C: Anodal tDCS+placebo-TENSPlacebo comparator 0 interventions
Group D: Control trainingPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
2

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.

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

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.

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

Secondary outcomes

1

10-Meter Walk Test (10MWT)

The subject will be asked to walk 10 meter in a comfortable speed. The completion time will be records by stopwatch. The test will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is.

Time frame
Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
2

Timed 'Up and Go' test (TUG)

The TUG is used to measure the functional mobility. Each subject will be required to rise from a chair with armrests, walk 3 m forward, turn around, return to the chair and sit down. The time taken to complete this task will be measured in seconds with a stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged.

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

Lower-extremity motor co-ordination test

The lower-extremity motor coordination test is used to measure the coordination of both the paretic and intact legs. Two red flat targets will be secured on the floor 30 cm apart. In sitting position with the feet resting flat on the floor and the heels on one of the targets, the participant will be instructed to touch 2 targets alternately with the big toe, as quickly and as accurately as possible, for 20 seconds. The number of times each target is touched will be counted. The more touch times indicated a better performance.

Time frame
Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
4

Gait Parameters (via GAITRite)

Gait parameters will be assessed using the GAITRite system (CIR system, Inc., Havertown, Pennsylvania), a pressure-sensitive mat that automatically captures spatiotemporal gait characteristics. Participants will walk at their self-selected comfortable pace along the instrumented walkway.

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

Other outcomes

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