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

Overview

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.

Interventions

• Behavioral MT
  A customised angle-adjustable frame with a mirror board (60 × 90 cm) will be used. All subjects are instructed to perform hip flexion/abduction, knee flexion/extension and ankle dorsiflexion/plantarflexion on the intact-limb during a 15 minutes period.
• Device TENS
  TENS will be delivered to the common peroneal nerve of the paretic leg. The stimulation frequency will be 100Hz and with an intensity just below the motor threshold.
• Behavioral Lower-limb task-oriented training
  The lower-limb task-oriented training comprises 6 exercises, namely stepping up and down, heel lift a dorsiflexed position, partial squatting, kicking a ball with alternate legs, gait re-education and transition training. Each exercise last for 10 minutes

Primary outcome measures

• The Change of Fugl-Meyer Assessment of Lower Extremity (FMA-LE) [Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)]

Secondary outcome measures (6)

• The Change of Paretic ankle dorsiflexor strength [Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)]
• The Change of Paretic ankle plantarflexor strength [Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)]
• The Change of 10-m walk test [Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)]
• The Change of Timed 'Up and Go' test [Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)]
• The Change of Lower-extremity motor co-ordination test [Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)]
• The Change of Cantonese version of Community Integration Measures (CIM-C) [Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)]

Eligibility criteria

Inclusion criteria

• 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;
• 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 unilateral neglect, hemianopia or apraxia;
• have no skin allergy (e.g. redness or itchiness to the electrical stimulation pads) to electrical stimulation or electrodes; and
• are able to follow instructions and give informed consent.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT03622879 · 2018_GRF_NG

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗