Stroke (Subacute)NCT06103045
The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function in Early Subacute Stroke.
A study testing unilateral and bilateral mirror therapy in people with Stroke (Subacute), run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke (Subacute)
- What is being tested?
- unilateral and bilateral mirror therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Feb 2023to 4 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Stroke (Subacute)
- Being tested
- unilateral and bilateral mirror therapy
- Keywords
- Stroke, unilateral mirror therapy, bilateral mirror therapy, motor function of upper extremity, early subacute
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral and bilateral mirror therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| unilateral mirror therapy (UMT) | Experimental | 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) Receives: Other: unilateral and bilateral mirror therapy |
| Bilateral Mirror Therapy (BMT) | Experimental | 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) Receives: Other: unilateral and bilateral mirror therapy |
| Conventional Occupational Therapy (COT) | Placebo comparator | 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) Receives: Other: unilateral and bilateral mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for upper extremity (FMA-UE)
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.
Measured: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
The Jamar Hydraulic Hand Dynamometer
The Jamar Hydraulic Hand Dynamometer is a gold standard assessment tool for measuring muscle power including the grip strength, palmar pinch, and lateral pinch.
Measured: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
Secondary outcomes (3)
Modified Ashworth Scale (MAS)
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.
Measured: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
Chedoke Arm and Hand Activity Inventory (CAHAI)
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.
Measured: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
Revised Nottingham Sensory Assessment (rNSA)
The rNSA is developed for assessing sensory function of patients with stroke. The reliability of rNSA was established in the past study.
Measured: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start7 Feb 2023
- Primary completion4 Jul 2025
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stroke (Subacute)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Yi Lin, MS, Study director, National Taiwan University Hospital Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103045
- Sponsor's protocol ID
- 111-168-E
- Status last verified
- May 2026
- First submitted
- 22 Oct 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15885874Geller 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.
PubMed 34538193Johnson 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.
PubMed 28222544Kidd 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.
PubMed 7858276Lee, 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.
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.
PubMed 28901119Perez-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.
PubMed 28032336Selles 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.
PubMed 24553103Zeng 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.
PubMed 29077129
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function in Early Subacute Stroke: A Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06103045
- Acronym / sponsor ID
- 111-168-E
- Conditions
- Stroke (Subacute)
- Keywords
- Stroke, unilateral mirror therapy, bilateral mirror therapy, motor function of upper extremity, early subacute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| unilateral mirror therapy (UMT) | Experimental | Other: unilateral and bilateral mirror therapyParticipants 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) |
| Bilateral Mirror Therapy (BMT) | Experimental | Other: unilateral and bilateral mirror therapyParticipants 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) |
| Conventional Occupational Therapy (COT) | Placebo comparator | Other: unilateral and bilateral mirror therapyParticipants 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) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unilateral and bilateral mirror therapyThe 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. | Other | Bilateral Mirror Therapy (BMT), Conventional Occupational Therapy (COT), unilateral mirror therapy (UMT) |
Primary outcome
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.
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.
3 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: 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
Revised Nottingham Sensory Assessment (rNSA)
Time frame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 15885874Cauraugh 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.
- Background: PubMed 34538193Geller 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.
- Background: PubMed 28222544Johnson 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.
- Background: PubMed 7858276Kidd 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.
- BackgroundLee, 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
- BackgroundLincoln, 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.
- Background: PubMed 28901119Meseguer-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.
- Background: PubMed 28032336Perez-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.
- Background: PubMed 24553103Selles 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.
- Background: PubMed 29077129Zeng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Yi Lin, MS study director
National Taiwan University Hospital Hsin-Chu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral and bilateral mirror therapy in people with Stroke (Subacute), run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103045, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.