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

The Effect of an Augmented Reality-Based Mirror Therapy System on Upper Extremity Motor Recovery and Functional Activity Level in Stroke Patients

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Augmented Reality-Based Mirror Therapy; Other: Conventional Physiotherapy Treatment; Other: Conventional Mirror Therapy

Detailed Description

The aim of this study is to develop an augmented reality-based mirror therapy system, MirrARm, based on sensor-based tracking and visual reflection principles, and to investigate its effects on upper extremity motor recovery and functional activity levels in patients with stroke.

In this study, individuals with stroke who meet the inclusion criteria will be randomly assigned into two groups using stratification based on age, sex, and Fugl-Meyer Upper Extremity scores. The groups will be the Augmented Reality-Based Mirror Therapy group (AR-MT) and the Conventional Mirror Therapy group (C-MT). All participants will receive conventional physiotherapy training for 30 minutes per session, three days per week, for eight weeks. Participants in the AR-MT group will additionally receive 30 minutes of exercise training using the MirrARm system three days per week for eight weeks, while participants in the C-MT group will receive exercise training using conventional mirror therapy for the same duration and frequency.

In this study, augmented reality-based mirror therapy training will be delivered using the MirrARm system. The MirrARm system will consist of a 27-inch computer monitor, a Leap Motion Controller motion-tracking sensor, and a laptop computer. The monitor will be placed on a work table and will display images transmitted from the connected laptop computer. The Leap Motion sensor will also be connected to the laptop computer and positioned on the table in front of the monitor. The Leap Motion sensor will be used to transfer participants' hand movements to the screen in real time. Through its software features, the MirrARm system will display movements performed with one hand on the screen as if they were being performed by the opposite hand.

The software infrastructure of the MirrARm system will be developed using the Unity 6.1 game engine. Participants' hand movements will be tracked with high precision in a three-dimensional environment using the official software development kits (SDKs) and libraries of the Leap Motion device. Applications will be designed using ready-made or customized Unity assets positioned within a three-dimensional coordinate system in the Unity environment, and realistic physical interactions will be provided through Unity's NVIDIA PhysX-based physics engine. The operation of the application will be controlled through custom MonoBehaviour-based scripts developed using the C# programming language. These scripts will dynamically manipulate Transform component properties of scene objects, including position, rotation, and scale; process user interactions through event-based triggers; and execute predefined functions within the game loop. Objects requiring physical interaction will be assigned Unity's Rigidbody component to provide physical properties such as mass, gravity, and collision responses, and interaction regions will be defined using Collider components.

During training sessions using the MirrARm system, participants with stroke will be seated in front of the screen on a back-supported chair and will perform the tasks included in gamified therapeutic activities using their unaffected upper limb, while observing these movements on the screen as if they were being performed by the affected upper limb.

Four different activities to be used in the MirrARm system have been designed by the researchers based on movements considered important for upper extremity functionality after stroke. Each activity has been designed with three levels of difficulty. Participants will perform each level for two minutes, with a 30-second rest period between levels. The task-oriented activities of the MirrARm system are as follows:

• Cube stacking activity (shoulder elevation-focused)
• Reaching activity (elbow extension-focused)
• Supination-pronation activity
• Horizontal ring activity (wrist extension-focused)

All participants included in the study will be assessed three times during the intervention period (Week 0, Week 4, and Week 8) using primary and secondary outcome measures by a blinded assessor.

All statistical analyses of the data obtained from participants will be performed using SPSS version 27.0 (IBM Corp., Armonk, NY, USA). Continuous variables will be reported as mean ± standard deviation when the assumption of normal distribution is met and as median (interquartile range) when it is not. Categorical variables will be reported as number (N) and percentage (%). Assumption checks will include the Shapiro-Wilk test for normality, Levene's test for homogeneity of variances, and Mauchly's test for sphericity; in cases of sphericity violation, the Greenhouse-Geisser correction will be applied. When assumptions are met, a two-way mixed-design (2×3) analysis of variance (ANOVA) will be conducted for each outcome measure. The main effects of time and group, as well as the time × group interaction, will be tested, and multiple comparisons will be performed using Bonferroni correction. Effect sizes will be reported as partial eta squared (η²p), with 95% confidence intervals and a significance level set at p = 0.05. When assumptions are not met, within-group changes across three time points will be analyzed using the Friedman test, followed by Bonferroni-corrected pairwise Wilcoxon tests if significant. Between-group comparisons will be performed using the Mann-Whitney U test based on change scores across time points. Nonparametric results will be reported with effect sizes, 95% confidence intervals, and a significance level of p = 0.05.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergen ÖZTÜRK, PhD Student; Phone Number: +90 555 408 3678; Email: ptsergenozturk@gmail.com
• Study Contact Backup: Name: Burcu ERSÖZ HÜSEYİNSİNOĞLU, Professor; Phone Number: +90 542 727 4316; Email: fztersoz@gmail.com

Study Locations

• Turkey (Türkiye)
  • Küçükçekmece
    • Istanbul, Küçükçekmece, Turkey (Türkiye), 34303
      • Acıbadem University Atakent Hospital
      • Contact: Ceyhun BAŞOĞLU, Physician, MD; Phone Number: +90 507 955 4826; Email: ceyhun.basoglu@acibadem.com
      • Sub-Investigator: Sergen Öztürk, Msc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented Reality-Based Mirror Therapy Group; 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; 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.; Other: Conventional Physiotherapy Treatment; 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.
Active Comparator: Conventional Mirror Therapy Group; 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 Physiotherapy Treatment; 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.; Other: Conventional Mirror Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Activity Log-28	The Motor Activity Log-28 (MAL-28) is a structured, self-reported assessment used to evaluate the amount of use and quality of movement of the affected upper limb during daily activities outside of therapy sessions. The scale consists of 28 items, each rated on a 6-point ordinal scale ranging from 0 to 5, where 0 indicates no use of the affected arm and 5 indicates use with the same frequency and quality as before the stroke.	Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).
Grip Strength	Grip strength of the affected upper limb will be measured using a hand dynamometer (SAEHAN Corporation, Korea; Model SH5001). Measurements will be performed with participants seated, feet flat on the floor, knees flexed at 90°, the arm positioned close to the body, elbow flexed at 90°, forearm in a neutral position, and wrist maintained in 0-30° of extension. Three consecutive measurements will be obtained, and the highest value will be recorded for analysis.	Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).

Collaborators and Investigators

• Sponsor: Marmara University
• Collaborators: Marmara University Scientific Research Projects Unit
• Investigators: Principal Investigator: Burcu ERSÖZ HÜSEYİNSİNOĞLU, Professor, Marmara University, Department of Physiotherapy and Rehabilitation; Study Director: Sergen ÖZTÜRK, PhD Student, Marmara University, Institute of Physiotherapy and Rehabilitation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Augmented Reality; Stroke Rehabilitation; Mirror Movement Therapy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: MU-FTR-PhD-2025/53-28

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