The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke

NCT07533734 | Not Yet Recruiting

• 1 other identifier: MU-FTR-PhD-2025/53-28
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objective The aim of this study is to investigate the effects of an augmented reality-based mirror therapy system (MirrARm), developed using sensor-based tracking and visual feedback principles, on upper extremity motor recovery and functional activity levels in patients with stroke. Research Questions This study seeks to address the following questions: Does the MirrARm system improve upper extremity motor recovery and functional activity levels in patients with stroke? Are the effects of the MirrARm system on upper extremity motor recovery and functional activity levels greater than those of conventional mirror therapy in patients with stroke? Study Design and Comparison The MirrARm system will be compared with conventional mirror therapy to evaluate its effectiveness in patients with stroke. Participants and Procedures Participants will take part in a treatment program administered three days per week for a total duration of eight weeks. Outcome measures will be assessed at baseline (Week 0), at mid-intervention (Week 4), and at the end of the intervention period (Week 8).

Conditions

Stroke

Keywords

Augmented Reality; Mirror Movement Therapy; Stroke Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Assessment - Upper Extremity

  The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based measure developed in Sweden by Fugl-Meyer and colleagues in 1975 to evaluate motor function, balance, sensation, and joint functioning in individuals after stroke. The upper extremity subscale (FM-UE) is widely regarded as the gold standard for assessing upper limb motor impairment and quantifying motor recovery following stroke.

  Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).

• Wolf Motor Function Test

  The Wolf Motor Function Test (WMFT) is a standardized assessment developed to evaluate upper extremity motor function in individuals with moderate to severe motor impairment. The test was originally developed by Wolf and colleagues and later modified by Morris and colleagues. The modified version of the WMFT will be used in this study. The WMFT consists of 17 tasks. For 15 tasks, data are collected in two domains: Functional ability and Performance time. The remaining two tasks assess upper extremity muscle strength and will not be included in the present study.

  Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).

• The Chedoke Arm and Hand Activity Inventory-9

  The Chedoke Arm and Hand Activity Inventory (CAHAI) is a standardized assessment with detailed administration and scoring guidelines designed to evaluate functional performance of the upper extremity in individuals after stroke. Because the original version is time-consuming to administer, a shortened 9-item version (CAHAI-9) was developed. The CAHAI-9 will be used in this study to assess functional upper limb activity.

  Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).

Secondary Outcomes (2)

• Motor Activity Log-28

  Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).

• Grip Strength

  Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).

Study Arms (2)

Augmented Reality-Based Mirror Therapy Group

EXPERIMENTAL

Participants in this group will undergo an 8-week training program administered three days per week. Each session will consist of 30 minutes of augmented reality-based mirror therapy exercise training using the MirrARm system developed by the research team, followed by 30 minutes of conventional physiotherapy treatment.

Other: Augmented Reality-Based Mirror Therapy; Other: Conventional Physiotherapy Treatment

Conventional Mirror Therapy Group

ACTIVE COMPARATOR

Participants in this group will undergo an 8-week training program administered three days per week. Each session will consist of 30 minutes of exercise training using a mirror box followed by 30 minutes of conventional physiotherapy treatment.

Other: Conventional Mirror Therapy; Other: Conventional Physiotherapy Treatment

Interventions

Augmented Reality-Based Mirror Therapy OTHER

The MirrARm system will consist of a 27-inch computer monitor placed on a work table, a Leap Motion Controller motion-tracking sensor, and a laptop computer. Task-oriented and activities will be developed using the Unity 6.1 game engine. During training, participants will be seated in a chair with back support and participants' hand movements will be visually mirrored according to mirror therapy principles. Movements performed with the unaffected upper limb will be displayed on the screen as if they were being executed by the affected limb. The MirrARm system will include four task-oriented activities such as: Cube stacking activity (Shoulder elevation-focused), Reaching activity (Elbow extension-focused), Supination-pronation activity, Door knocking activity (Wrist extension-focused). Each activity will consist of three progressively increasing difficulty levels. Participants will perform each level for two minutes, with a 30-second rest period between levels and between activities.

Augmented Reality-Based Mirror Therapy Group

Conventional Mirror Therapy OTHER

In conventional mirror therapy training, participants will be seated on a back-supported chair at a table, with a mirror (60 cm × 50 cm) positioned vertically between the upper limbs, facing the unaffected arm. Task-oriented activities will be performed with the unaffected upper limb and observed in the mirror as if executed by the affected limb, in accordance with mirror therapy principles. The same activities used in the MirrARm system will be performed using real objects. Each activity level will be applied for two minutes, with 30-second rest periods, for a total duration of 30 minutes per session.

Conventional Mirror Therapy Group

Conventional Physiotherapy Treatment OTHER

Conventional physiotherapy treatment will include neurophysiological approaches based on strengthening, stretching, and coordination exercises for the affected upper limb, as well as neuromuscular electrical stimulation.

Augmented Reality-Based Mirror Therapy Group; Conventional Mirror Therapy Group

Eligibility Criteria

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

You may qualify if:

• First-ever unilateral stroke diagnosed by a specialist physician,
• Presence of post-stroke hemiplegia,
• Age ≥ 18 years,
• Time since stroke between 3 and 12 months,
• Score ≥ 24 on the Standardized Mini-Mental State Examination,
• Upper extremity motor score ≤ 22 on the Fugl-Meyer Assessment.

You may not qualify if:

• Inability to sit independently in a supported chair,
• Insufficient communication ability due to aphasia,
• Presence of structural and/or acquired impairments limiting active movement of the unaffected upper limb,
• Presence of visual or visual-perceptual impairments,
• Presence of unilateral neglect,
• Presence of neurological, psychiatric, cognitive, or oncological disorders other than stroke.

Sponsors & Collaborators

• Marmara University: lead
• Marmara University Scientific Research Projects Unit: collaborator

Study Sites (1)

Acıbadem University Atakent Hospital

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

Location

Related Publications (8)

• Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.

  PMID: 21624928 RESULT

• Ersoz Huseyinsinoglu, B., Ozdincler, A., Oğul, Ö., & Krespi, Y. (2011). Reliability And Validity Of Turkish Version Of Motor Activity Log-28. Turk Noroloji Dergisi, 17, 83-89.

  RESULT

• Barreca SR, Stratford PW, Masters LM, Lambert CL, Griffiths J. Comparing 2 versions of the Chedoke Arm and Hand Activity Inventory with the Action Research Arm Test. Phys Ther. 2006 Feb;86(2):245-53.

  PMID: 16445338 RESULT

• Barreca S, Gowland CK, Stratford P, Huijbregts M, Griffiths J, Torresin W, Dunkley M, Miller P, Masters L. Development of the Chedoke Arm and Hand Activity Inventory: theoretical constructs, item generation, and selection. Top Stroke Rehabil. 2004 Fall;11(4):31-42. doi: 10.1310/JU8P-UVK6-68VW-CF3W.

  PMID: 15592988 RESULT

• Wolf SL, Lecraw DE, Barton LA, Jann BB. Forced use of hemiplegic upper extremities to reverse the effect of learned nonuse among chronic stroke and head-injured patients. Exp Neurol. 1989 May;104(2):125-32. doi: 10.1016/s0014-4886(89)80005-6.

  PMID: 2707361 RESULT

• Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.

  PMID: 11387578 RESULT

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

  PMID: 1135616 RESULT

• Mekbib DB, Debeli DK, Zhang L, Fang S, Shao Y, Yang W, Han J, Jiang H, Zhu J, Zhao Z, Cheng R, Ye X, Zhang J, Xu D. A novel fully immersive virtual reality environment for upper extremity rehabilitation in patients with stroke. Ann N Y Acad Sci. 2021 Jun;1493(1):75-89. doi: 10.1111/nyas.14554. Epub 2021 Jan 14.

  PMID: 33442915 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Burcu ERSÖZ HÜSEYİNSİNOĞLU, Professor

  Marmara University, Department of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Sergen ÖZTÜRK, PhD Student

  Marmara University, Institute of Physiotherapy and Rehabilitation

  STUDY DIRECTOR

Central Study Contacts

Sergen ÖZTÜRK, PhD Student

CONTACT

+90 555 408 3678; ptsergenozturk@gmail.com

Burcu ERSÖZ HÜSEYİNSİNOĞLU, Professor

CONTACT

+90 542 727 4316; fztersoz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Separate participant information forms will be prepared for each study group. This approach will ensure that participants are not informed about the intervention applied in the other group. The researcher responsible for assessing the outcome measures will be blinded to participants' group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed as a randomized controlled trial. For randomization, a computer-generated randomization table will be created using the website www.randomizer.org. To ensure balanced allocation between groups, stratification will be performed based on age (\<40 years, 40-65 years, \>65 years), sex (male/female), and Fugl-Meyer Upper Extremity score (\<10 and 10-22). Participants will be assigned to the study groups according to the order of enrollment in accordance with the randomization table.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)