Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke

September 1, 2020 updated by: China Medical University Hospital

Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke: a Pilot Randomized-controlled Trial

The study purpose is to compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients.

Study Overview

Status

Status

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

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

Study background: Approximately 80% of stroke survivors have an upper and/or lower limb impairment (Barker 1997), and impairment of the arm explains up to 50% of the variance in functional limitation after stroke. Brain imaging research using magnetoencephalography found that mirror therapy combined with bilateral arm training could potentially aid stroke rehabilitation by normalizing an asymmetrical pattern of movement-related beta desynchronization in primary motor cortex. However, different neural mechanisms may cause different effect of motor control recovery after the two different approaches, which have yet to be studied. Study purpose：To compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients. Study method: This was a single-blind, randomized, comparative efficacy research. Sixty participants with chronic stroke will be recruited in the occupational therapy clinics at four hospitals and randomly assigned to the mirror therapy and bilateral arm training groups. The intervention will consist of 1.5 hrs/day, 5 days/wk for 4 wks, including 3 days of hospital-based therapy and 5 days of home practice. Primary outcomes were muscular properties (grip strength) and sensorimotor measurements. Secondary outcomes included measures of daily functions to gain insight about movement capabilities. The validity and reliability of all measurements have been proposed. Finally, the Mann-Whitney U test and the Fisher exact test will be used to compare the significant differences between the two approaches. The effect size of dependent variables will be reported also.

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 (Actual)

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.
29

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 Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital

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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • more than 6 months after onset of an ischemic or hemorrhage stroke
  • no excessive spasticity on all joints of the affected arm

Exclusion Criteria:

  • history of stroke or other neurologic, neuromuscular, or orthopedic disease
  • participation in other experimental rehabilitation or drug studies concurrent with this study

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
  • 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: Mirror therapy
Mirror therapy group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.
Other: Mirror therapy
Mirror therapy group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.
EXPERIMENTAL: Bilateral arm training
Bilateral arm training group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.
Other: Bilateral arm training
Bilateral arm training group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.

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 efficacy of mirror therapy versus bilateral arm training on sensorimotor functions
Time Frame: within four weeks (plus or minus 3 days) after intervention
Revised Nottingham Sensory Assessment and Fugl-Meyer Assessment will be used to measure sensorimotor functions. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.
within four weeks (plus or minus 3 days) after intervention

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 efficacy of mirror therapy versus bilateral arm training on motor performance
Time Frame: within four weeks (plus or minus 3 days) after intervention
The Chedoke Arm and Hand Activity Inventory (CAHAI) will be used to measure arm and hand functions on real-life bilateral tasks. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training on motor performance.
within four weeks (plus or minus 3 days) after intervention
The efficacy of mirror therapy versus bilateral arm training on motor performance
Time Frame: within four weeks (plus or minus 3 days) after intervention
Motor Activity Log (MAL) will be used to measure self-perceived real-world use. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.
within four weeks (plus or minus 3 days) after intervention
The efficacy of mirror therapy versus bilateral arm training on quality of life
Time Frame: within four weeks (plus or minus 3 days) after intervention
Stroke Impact Scale Version 3.0 (SIS) will be used to measure patient reported quality of life and multidimensional stroke recovery. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.
within four weeks (plus or minus 3 days) after intervention

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.
China Medical University Hospital

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: Keh-chung Lin, ScD, National Taiwan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
September 11, 2015

Primary Completion (ACTUAL)

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.
October 6, 2017

Study Completion (ACTUAL)

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.
October 6, 2017

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).
September 9, 2015

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.
September 10, 2015

First Posted (ESTIMATE)

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.
September 14, 2015

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.
September 3, 2020

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.
September 1, 2020

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.
September 1, 2020

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.
  • CMUH104-REC3-052

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