Mirror Therapy with Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in Stroke

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: MT; Device: TENS; Behavioral: Lower-limb task-oriented training

Study type: Interventional

Funder types: Other

Identifiers

NCT03622879

2018_GRF_NG

Details and patient eligibility

About

This study aims to evaluate the effectiveness of concurrent mirror therapy (MT) 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 MT combined with TENS would be superior to sham-mirror therapy with TENS, or MT with placebo-TENS, or control training only in improving lower limb motor functions and walking ability in people with stroke when combined with the lower limb task-oriented training.

Full description

The application of transcutaneous electrical nerve stimulation (TENS) over a paretic lower limb could augment the effects of task-oriented exercise therapy on lower limb motor function in people with stroke, possibly through increased excitability of sensorimotor cortex.

In mirror therapy (MT), the intact limb performs motor tasks while its mirror reflection is superimposed over the covered paretic limb, creating a visual illusion of enhanced function over the paretic limb. The visual input during MT could substitute for reduced proprioceptive inputs and increase spatial attention of the paretic limb, which could improve motor function of the paretic limb, possibly through increased cortical activity in the lesioned hemisphere and mirror neurone system.

The next question concerns whether MT could be combined with TENS and whether their synergetic effects could maximise the motor output of paretic limbs in people with stroke.

Enrollment: 100 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. have had a single stroke with ischemic brain injury or intracerebral haemorrhage diagnosed by magnetic resonance imaging or computed tomography within the previous 6 to 36 months;
2. have at least 5 degrees of active ankle dorsiflexion in the antigravity position;
3. are able to walk 10 m independently with or without a walking aid;
4. are able to score 6 or higher out of 10 on the abbreviated mental test;
5. have no unilateral neglect, hemianopia or apraxia;
6. have no skin allergy (e.g. redness or itchiness to the electrical stimulation pads) to electrical stimulation or electrodes; and
7. are able to follow instructions and give informed consent.

Exclusion criteria

1. have any additional medical, cardiovascular or orthopaedic condition that would hinder proper treatment or assessment;
2. have visual deficits that may hinder them from benefiting from the mirror visual feedback;
3. have receptive dysphasia; or
4. are involved in drug studies or other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups, including a placebo group

MT + TENS

Experimental group

Description:

The subject will adopt a semi-seated position on a bed while the mirror board is positioned between the legs perpendicular to the subject's midline. The paretic leg will be positioned behind the mirror, with the intact leg facing the reflective surface. All subjects will be reminded to focus on the image in the mirror during MT training. All subjects will receive concurrent TENS stimulation over the common peroneal nerve while practising bilateral lower limb exercises. After 15 minutes of priming with TENS + MT, all subjects will perform 60 minutes of lower limb task-oriented training.

Treatment:

Behavioral: Lower-limb task-oriented training

Device: TENS

Behavioral: MT

Placebo-MT+TENS

Placebo Comparator group

Description:

In the Placebo-MT+TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group, except that the reflecting surface of the angle-adjustable mirror was covered with paper. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training.

Treatment:

Behavioral: Lower-limb task-oriented training

Device: TENS

MT+placebo-TENS

Placebo Comparator group

Description:

In the MT+placebo-TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group. The only difference is that placebo stimulation will be applied to the paretic limb from identical-looking TENS devices with the electrical circuit disconnected inside. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training.

Treatment:

Behavioral: Lower-limb task-oriented training

Behavioral: MT

control training

Sham Comparator group

Description:

All subjects will perform 60 minutes of lower limb task-oriented training only.

Treatment:

Behavioral: Lower-limb task-oriented training