The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarmara University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Augmented Reality-Based Mirror Therapy
Other interventionThe 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
Other interventionIn 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
Other interventionConventional physiotherapy treatment will include neurophysiological approaches based on strengthening, stretching, and coordination exercises for the affected upper limb, as well as neuromuscular electrical stimulation.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Augmented Reality-Based Mirror Therapy GroupExperimental treatment 2 interventions
Group B: Conventional Mirror Therapy GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).2
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.
Time frame
Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).3
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.
Time frame
Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).Secondary outcomes
1
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.
Time frame
Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).2
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.
Time frame
Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).Sponsors and contacts
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Marmara University
Lead sponsor
Marmara University Scientific Research Projects Unit
Collaborator
Source ClinicalTrials.gov
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