The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function of Stroke at Acute Stage.

NCT ID: NCT06103045

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2025-07-04

Brief Summary

Objective: To comparing the effects of unilateral and bilateral mirror therapy on upper extremity function of stroke at acute stage. We hypothesize there are different effects between unilateral and bilateral mirror therapy on stroke patients at acute 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), the Revised Nottingham Sensory Assessment (rNSA), and Functional Independence Measurement (FIM).

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

unilateral and bilateral mirror therapy

Intervention Type: OTHER

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.

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)

Group Type: EXPERIMENTAL

unilateral and bilateral mirror therapy

Intervention Type: OTHER

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.

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)

Group Type: PLACEBO_COMPARATOR

unilateral and bilateral mirror therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chia-Yi Lin, MS

Role: STUDY_DIRECTOR

National Taiwan University Hospital Hsin-Chu Branch

Locations

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 15885874 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34538193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28222544 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7858276 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 28901119 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28032336 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24553103 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29077129 (View on PubMed)

Other Identifiers

111-168-E

Identifier Type: -

Identifier Source: org_study_id