The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function in Early Subacute Stroke.

May 18, 2026 updated by: National Taiwan University Hospital Hsin-Chu Branch

The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function in Early Subacute Stroke: A Pilot Randomized Controlled Trial.

Objective: To comparing the effects of unilateral and bilateral mirror therapy on upper extremity function of stroke at early subacute stage. We hypothesize there are different effects between unilateral and bilateral mirror therapy on stroke patients at early subacute stage. Method: Patients with unilateral stroke and the onset within one month will be recruited and then randomly allocated to one of the three groups (including unilateral mirror therapy, bilateral mirror therapy, and conventional occupational therapy). Patient will receive 20 consecutive sessions of intervention (5 time per week, totally 4 weeks) and assessments before and after the intervention within one week. In each intervention session, patients will receive 30 minutes unilateral or bilateral mirror therapy depending on their allocated groups and then 30 conventional occupational therapy. The patients recruited in the conventional occupational therapy group will receive 60 minute conventional therapy. The outcome measures at pre- and post-treatment will including the Fugl-Meyer Assessment for upper extremity (FMA-UE), the Modified Ashworth Scale (MAS), the Jamar Hydraulic Hand Dynamometer, the Chedoke Arm and Hand Activity Inventory (CAHAI), and the Revised Nottingham Sensory Assessment (rNSA).

Study Overview

Status

Status

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

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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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.
49

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

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Study Locations

  • Taiwan
      • Hsinchu, Taiwan, 300
        • National Taiwan University Hospital Hsin-Chu Branch

Participation Criteria

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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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Unilateral stroke onset within 1 month
  • The score of Mini-Mental State Examination (MMSE) is more than 24
  • The score of Fugl-Meyer Assessment for upper extremity (FMA-UE) is between 18 to 56
  • The score of Modified Ashworth Scale (MAS) is less than 3
  • Willing to receive 3-5 sessions of the intervention per week, total 20 sessions consecutively
  • Willing to sign informed consent

Exclusion Criteria:

  • Unstable vital sign or complicating with other symptoms of neurological disease
  • Auditory or visual function impairment
  • Complicating with perceptual impairment (e.g., apraxia, neglect, or visual agnosia)
  • Receiving botulinum toxin injection within 3 months
  • Complicating with Wernicke's or Broca's aphasia

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: unilateral mirror therapy (UMT)
Participants will receive 30 minutes unilateral mirror therapy and then 30 minutes conventional occupational therapy in each treatment session. there will be 20 consecutive sessions (5 times per week, lasting 4 weeks totally)
Other: unilateral and bilateral mirror therapy
The mirror box is placed on a table in the sagittal plane of the participant. The affected upper extremity of the participant is hidden in the morror box and the unaffected upper extremity is placed symmetrically. During the unilateral or bilateral mirror therapy, the participant is requested to execute a serial of movements and tasks and pay attention on observing the reflection of the unaffected side in the mirror simultaneously. In the bilateral mirror therapy, the participant also has to move the affected upper extremity simultaneously; while in the unilateral mirror therapy, the participant only keeps the affected side relaxed.
Experimental: Bilateral Mirror Therapy (BMT)
Participants will receive 30 minutes bilateral mirror therapy and then 30 minutes conventional occupational therapy in each treatment session. there will be 20 consecutive sessions (5 times per week, lasting 4 weeks totally)
Other: unilateral and bilateral mirror therapy
The mirror box is placed on a table in the sagittal plane of the participant. The affected upper extremity of the participant is hidden in the morror box and the unaffected upper extremity is placed symmetrically. During the unilateral or bilateral mirror therapy, the participant is requested to execute a serial of movements and tasks and pay attention on observing the reflection of the unaffected side in the mirror simultaneously. In the bilateral mirror therapy, the participant also has to move the affected upper extremity simultaneously; while in the unilateral mirror therapy, the participant only keeps the affected side relaxed.
Placebo Comparator: Conventional Occupational Therapy (COT)
Participants will receive 60 minutes conventional occupational therapy in each treatment session. there will be 20 consecutive sessions (5 times per week, lasting 4 weeks totally)
Other: unilateral and bilateral mirror therapy
The mirror box is placed on a table in the sagittal plane of the participant. The affected upper extremity of the participant is hidden in the morror box and the unaffected upper extremity is placed symmetrically. During the unilateral or bilateral mirror therapy, the participant is requested to execute a serial of movements and tasks and pay attention on observing the reflection of the unaffected side in the mirror simultaneously. In the bilateral mirror therapy, the participant also has to move the affected upper extremity simultaneously; while in the unilateral mirror therapy, the participant only keeps the affected side relaxed.

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
Fugl-Meyer Assessment for upper extremity (FMA-UE)
Time Frame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
The FMA-UE is a commonly used assessment in clinical for the extent of motor impairment of upper extremity post-stroke. The score ranged from 0 to 66. The psychometric properties of the FMA-UE had established, and there was also good responsiveness in the past studies.
pre-treatment: before intervention within a week; post-treatment: after intervention within a week
The Jamar Hydraulic Hand Dynamometer
Time Frame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
The Jamar Hydraulic Hand Dynamometer is a gold standard assessment tool for measuring muscle power including the grip strength, palmar pinch, and lateral pinch.
pre-treatment: before intervention within a week; post-treatment: after intervention within a week

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
Modified Ashworth Scale (MAS)
Time Frame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
The MAS is a clinical measurement for muscle spasticity. The score is ranged from 0 to 4. The shoulder, elbow, forearm, wrist, and fingers will be assessed. The psychometric properties of the MAS had established in the past studies.
pre-treatment: before intervention within a week; post-treatment: after intervention within a week
Chedoke Arm and Hand Activity Inventory (CAHAI)
Time Frame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
The CAHAI is used for the involvement of the impairment upper extremity during the bimanual tasks. There are 13 item and each score is ranged from 1-7. The psychometric properties of the CAHAI had established in the past studies.
pre-treatment: before intervention within a week; post-treatment: after intervention within a week
Revised Nottingham Sensory Assessment (rNSA)
Time Frame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
The rNSA is developed for assessing sensory function of patients with stroke. The reliability of rNSA was established in the past study.
pre-treatment: before intervention within a week; post-treatment: after intervention within a week

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.
National Taiwan University Hospital Hsin-Chu Branch

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.
  • Study Director: Chia-Yi Lin, MS, National Taiwan University Hospital Hsin-Chu Branch

Publications and helpful links

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General Publications

Study record dates

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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.
February 7, 2023

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.
July 4, 2025

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.
July 4, 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).
October 22, 2023

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.
October 22, 2023

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.
October 26, 2023

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.
May 20, 2026

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.
May 18, 2026

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.
May 1, 2026

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.
  • 111-168-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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