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

NCT06103045 | Completed

• 1 other identifier: 111-168-E
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; unilateral mirror therapy; bilateral mirror therapy; acute stage; motor function of upper extremity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  pre-treatment: before intervention within a week; post-treatment: after intervention within a week

Secondary Outcomes (4)

• Modified Ashworth Scale (MAS)

  pre-treatment: before intervention within a week; post-treatment: after intervention within a week

• Chedoke Arm and Hand Activity Inventory (CAHAI)

  pre-treatment: before intervention within a week; post-treatment: after intervention within a week

• Functional Independence Measurement (FIM)

  pre-treatment: before intervention within a week; post-treatment: after intervention within a week

• Revised Nottingham Sensory Assessment (rNSA)

  pre-treatment: before intervention within a week; post-treatment: after intervention within a week

Study Arms (3)

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)

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)

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)

Other: unilateral and bilateral mirror therapy

Interventions

unilateral and bilateral mirror therapy 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); Conventional Occupational Therapy (COT); unilateral mirror therapy (UMT)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300, Taiwan

Location

Related Publications (10)

• 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.

  PMID: 15885874 BACKGROUND

• 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.

  PMID: 34538193 BACKGROUND

• 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.

  PMID: 28222544 BACKGROUND

• 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.

  PMID: 7858276 BACKGROUND

• 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

  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.

  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.

  PMID: 28901119 BACKGROUND

• 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.

  PMID: 28032336 BACKGROUND

• 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.

  PMID: 24553103 BACKGROUND

• 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.

  PMID: 29077129 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chia-Yi Lin, MS

  National Taiwan University Hospital Hsin-Chu Branch

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors in charrge of pre- and post-test assessments were blinded to randomized allocation and intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: February 7, 2023
• Primary Completion: July 4, 2025
• Study Completion: July 4, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)