- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06103045
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- 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
-
-
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Hsinchu, Taiwan, 300
- National Taiwan University Hospital Hsin-Chu Branch
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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
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 |
Intervention / Treatment |
|---|---|
|
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)
|
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)
|
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)
|
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
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
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.
Investigators
- Study Director: Chia-Yi Lin, MS, National Taiwan University Hospital Hsin-Chu Branch
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
- Cauraugh JH, Summers JJ. Neural plasticity and bilateral movements: A rehabilitation approach for chronic stroke. Prog Neurobiol. 2005 Apr;75(5):309-20. doi: 10.1016/j.pneurobio.2005.04.001.
- Zeng W, Guo Y, Wu G, Liu X, Fang Q. Mirror therapy for motor function of the upper extremity in patients with stroke: A meta-analysis. J Rehabil Med. 2018 Jan 10;50(1):8-15. doi: 10.2340/16501977-2287.
- Kidd D, Stewart G, Baldry J, Johnson J, Rossiter D, Petruckevitch A, Thompson AJ. The Functional Independence Measure: a comparative validity and reliability study. Disabil Rehabil. 1995 Jan;17(1):10-4. doi: 10.3109/09638289509166622.
- Meseguer-Henarejos AB, Sanchez-Meca J, Lopez-Pina JA, Carles-Hernandez R. Inter- and intra-rater reliability of the Modified Ashworth Scale: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2018 Aug;54(4):576-590. doi: 10.23736/S1973-9087.17.04796-7. Epub 2017 Sep 13.
- Geller D, Nilsen DM, Quinn L, Van Lew S, Bayona C, Gillen G. Home mirror therapy: a randomized controlled pilot study comparing unimanual and bimanual mirror therapy for improved arm and hand function post-stroke. Disabil Rehabil. 2022 Nov;44(22):6766-6774. doi: 10.1080/09638288.2021.1973121. Epub 2021 Sep 19.
- Johnson D, Harris J, Stratford P, Richardson J. Inter-rater reliability of the Chedoke Arm and Hand Activity Inventory. NeuroRehabilitation. 2017;40(2):201-209. doi: 10.3233/NRE-161405.
- Lee, M. T., Lu, Y. Y., Wu, C. Y., Hsieh, Y. W., & Lin, K.C. (2012). A systematic review of the effects of mirror therapy in patients with stroke. Journal of Taiwan Occupational Therapy Research and Practice, 8 (2), 125-140. doi:10.6534/jtotrp.2012.8(2).125
- Lincoln, N. B., Jackson, J. M., & Adams, S. A. (1998). Reliability and revision of the Nottingham Sensory Assessment for stroke patients. Physiotherapy, 84(8), 358- 365.
- Perez-Cruzado D, Merchan-Baeza JA, Gonzalez-Sanchez M, Cuesta-Vargas AI. Systematic review of mirror therapy compared with conventional rehabilitation in upper extremity function in stroke survivors. Aust Occup Ther J. 2017 Apr;64(2):91-112. doi: 10.1111/1440-1630.12342. Epub 2016 Dec 29.
- Selles RW, Michielsen ME, Bussmann JB, Stam HJ, Hurkmans HL, Heijnen I, de Groot D, Ribbers GM. Effects of a mirror-induced visual illusion on a reaching task in stroke patients: implications for mirror therapy training. Neurorehabil Neural Repair. 2014 Sep;28(7):652-9. doi: 10.1177/1545968314521005. Epub 2014 Feb 18.
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)
February 7, 2023
Primary Completion (Actual)
July 4, 2025
Study Completion (Actual)
July 4, 2025
Study Registration Dates
First Submitted
October 22, 2023
First Submitted That Met QC Criteria
October 22, 2023
First Posted (Actual)
October 26, 2023
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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