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

NCT07533734 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-07-01
Last updated
2026-04-16

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

Augmented Reality-Based Mirror TherapyConventional Mirror TherapyConventional Physiotherapy Treatment

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.

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.

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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Fugl-Meyer Assessment - Upper Extremity — Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).
    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.
  • Wolf Motor Function Test — Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).
    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.
  • The Chedoke Arm and Hand Activity Inventory-9 — 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 (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.

Trial sites (1)

FacilityCityRegionStatus
Acıbadem University Atakent Hospital Istanbul Küçükçekmece
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07533734 on ClinicalTrials.gov ↗ ← All trials in Turkey