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

Official title

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

Overview

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).

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.

Interventions

• 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
• 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
• 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.

Primary outcome measures

• Fugl-Meyer Assessment - Upper Extremity [Time frame: 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 [Time frame: 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 [Time frame: Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).]

Secondary outcome measures (2)

• Motor Activity Log-28 [Time frame: Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).]
• Grip Strength [Time frame: Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Acıbadem University Atakent Hospital — Istanbul

Publications

• 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
• 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. PMID 16445338
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07533734 · MU-FTR-PhD-2025/53-28

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗