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

October 1, 2024 updated by: Shamay Ng, The Hong Kong Polytechnic University

Effect of Mirror Therapy with Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in People with Stroke: a Single-blinded Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Hong Kong Polytechnic University
        • Contact:
        • Contact:
          • SSM Ng, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MT + TENS
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.
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
Placebo Comparator: Placebo-MT+TENS
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.
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
Placebo Comparator: MT+placebo-TENS
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.
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.
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
Sham Comparator: control training
All subjects will perform 60 minutes of lower limb task-oriented training only.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 subject's 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. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
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 subject's 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 average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle plantarflexor strength. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
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)
10-m walk test is used to measure the walking speed in a short distance. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time indicated the better performance in 10-m walk test. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
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 Time 'Up and Go' test 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. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
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 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. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
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)
The level of community integration will be assessed by the Cantonese version of Community Integration Measures (CIM-C). The CIM is a client-centred questionnaire with 10 items; each item rating from 1 to 5 with a total score from 10 to 50. A higher CIM-C score indicates a higher level of community integration. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SSM Ng, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018_GRF_NG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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