Clinical trial NCT03622879: Mirror Therapy with Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in Stroke
Official title: Effect of Mirror Therapy with Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in People with Stroke: a Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Mirror therapy
Transcutaneous Electric Nerve Stimulation
Rehabilitation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Change of Fugl-Meyer Assessment of Lower Extremity (FMA-LE)
timeFrame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
Secondary outcomes:
measure: The Change of Paretic ankle dorsiflexor strength
timeFrame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
measure: The Change of Paretic ankle plantarflexor strength
timeFrame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
measure: The Change of 10-m walk test
timeFrame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
measure: The Change of Timed 'Up and Go' test
timeFrame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
measure: The Change of Lower-extremity motor co-ordination test
timeFrame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
measure: The Change of Cantonese version of Community Integration Measures (CIM-C)
timeFrame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: SSM Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: