Virtual Reality Based Mirror Therapy

Sponsor
Abant Izzet Baysal University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06152328
Collaborator
(none)
58
1
2
19
3.1

Study Details

Study Description

Brief Summary

The aim of this study is to examine the effectiveness of 3D virtual reality assisted mirror therapy based rehabilitation applications compared to classical methods used in stroke rehabilitation.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality applications based on mirror therapy
  • Other: Conventional treatment
N/A

Detailed Description

Stroke is a common neurological condition and one of the significant causes of disability and death. For this reason, stroke is one of the leading causes of disability in adulthood and increases health expenditures in this area. Post-stroke rehabilitation is effective in accelerating recovery and reducing the impact of long-term disabilities, but more studies are needed to understand its specific implications.

Virtual reality applications are a method that has been developing rapidly with the development of technology since the 1980s and is used more widely in simulations and games today. Virtual reality and interactive video games have started to be used as a new treatment method in stroke rehabilitation. The advantage of this method is that it allows the patient to use activity methods that cannot be reached or used in the clinical setting, with plenty of repetitive and visual feedback. Moreover, virtual reality programs are designed to be more entertaining and sustainable for a long time compared to traditional treatment programs. There are no virtual reality devices specially designed for treatment, but the game consoles used in the market are modified for this purpose and used comfortably.

Oculus rift is a console that can create a real virtual reality environment. The individual has a realistic experience by seeing his own avatar and interacting with objects in a world where he will be 360-degree interactive in a designed environment completely isolated from the external environment. It is the most advanced technology of virtual reality applications used today, and it increases the individual's feeling of being in a 3D environment with glasses that use the entire visual field of the person and headphones for the transmission of sounds.

As an alternative treatment approach, mirror therapy has been suggested to be beneficial. Unlike other interventions that use somatosensory input to aid motor recovery, mirror therapy relies on visual stimulation. During mirror therapy, a mirror is placed in the patient's midsagittal plane so that the nonparetic side is mirrored as if it were the affected side. The advantages of mirror therapy are that it is relatively easy to administer and can be self-administered, even for patients with severe motor deficits.

Mirror therapy is claimed to alleviate post-stroke hemiparesis. Studies confirm the positive effects of mirror therapy on patients' mobility in post-stroke upper extremity hemiparesis. The concept of mirror therapy is explained neurophysiologically. Evidence suggests that the same cortical motor areas that are active during the observation of movements are involved in the performance of observed actions.

With the environment to be prepared in virtual reality, the individual will see the exact copy of the movements of the healthy side as the movement of the affected extremity. According to the activity to be selected, the image will be projected as if the affected side is doing the same or the opposite movement. Oculus rift has a structure that covers the entire field of vision with its glasses-shaped apparatus and insulates sounds from outside with its earphones. In this way, it will give the person the feeling of being in the environment much more than the non-immersive virtual reality treatments frequently used in previous studies. The person will see the avatar created in the virtual world in real-time, and the movements will turn into an instant image. The image will cover the person's visual field as in the real world, and the person will see their own body through their own eyes throughout the application.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The assessor will not know which group the patients are in.
Primary Purpose:
Treatment
Official Title:
A New Perspective on Mirror Therapy: The Effect of Leap Motion-Based Multi-Axis Immersive Virtual Reality Mirror Therapy (LISA) on Upper Extremity Functions in Individuals With Stroke
Actual Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
May 15, 2025
Anticipated Study Completion Date :
Jun 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: VR group

During the exercise, games will be selected from the movements that focus on upper extremity function and require the use of both extremities. These functions will be to grasp the object with both hands, to throw the object, and to provide the object's rotation by revealing the hand's supination-pronation movement. During these movements, the image of the healthy side will be mirrored to the affected side. Before each exercise, what kind of movement requested from the patient will be shown in the VR environment.

Other: Virtual reality applications based on mirror therapy
Mirror therapy-based games will be played for 30 minutes every day for eight weeks, five days a week, for the VR group.

Active Comparator: Control group

Bobath therapy, walking exercises, upper extremity active exercises, proprioceptive neuromuscular facilitation techniques, which are traditional physical therapy and rehabilitation methods, will be applied to the control group.

Other: Conventional treatment
Bobath therapy, walking exercises, upper extremity active exercises, and proprioceptive neuromuscular facilitation techniques will be applied three days a week for eight weeks.

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment [on average 18 months until the completion of the study]

    It is a scale based on measuring upper extremity performance in stroke patients. Test; reflex activity, flexor and extensor synergy, combined synergistic movements, non-synergy movements, normal reflex activity, wrist and hand evaluation, coordination and speed evaluation subsections. It consists of 33 items in total, and each item is scored between 0 and 2 points (0: unable, 1: partially able, 2: fully able). The total score is 66.

Secondary Outcome Measures

  1. Evaluation of Cortical Activation with EEG [on average 18 months until the completion of the study]

    EEG signals will be recorded over the mu rhythm during rest and imagery tasks. Mu rhythm activity increases during rest and is suppressed during purposeful exercise or activity observation. This mu rhythm suppression is expressed as activation of relevant brain areas.

  2. Motor Activity Log-28 [on average 18 months until the completion of the study]

    It will be used to assess the spontaneous use of the hemiparetic limb in daily life. The MAG-28 is one of the commonly used assessment tools to assess activity according to the ICF. The MAG-28 consists of two scales and assesses the frequency of use and quality of movement of the affected upper extremity during 28 activities of daily living such as buttoning a shirt, opening a drawer, brushing teeth.

  3. Simulator Sickness Questionnaire [on average 18 months until the completion of the study]

    It has been widely used to assess various forms of illness triggered by virtual environments. It is constructed by transforming symptoms that participants subjectively report the presence and severity of on a scale. The Simulator Sickness Questionnaire assesses 16 symptoms such as eyestrain, nausea, sweating and headache on 4 different severity ratings (none, mild, moderate and severe)

  4. System Usability Scale [on average 18 months until the completion of the study]

    It consists of 10 statements that allow evaluating the ease of use (or lack thereof) of websites, software, hardware, mobile devices and other technological applications at a glance. Using a 5-point Likert scale, the SUS is basically a questionnaire for assessing usability and has Turkish validity

  5. Stroke-Specific Quality of Life Scale [on average 18 months until the completion of the study]

    It is a stroke-specific, 49-item assessment covering 12 domains to measure quality of life. It measures upper limb function, vision, speech, domestic roles, social roles, mobility, psychological status, work productivity, self-care, perception, memory and personality.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Have a ischemic stroke

  • Stroke duration not less than 2 months and not more than 6 months

  • Individuals with a score of 2b and 3 according to the Thrombolysis in cerebral infarction (TICI) scale

  • A score of 2 and above according to the upper extremity motor assessment of the NIH stroke scale

  • Intact depth perception in the Titmus Stereopsis assessment

  • A score of 24 and above in the Mini-mental test and

  • Independent sitting balance

Exclusion Criteria:
  • Additional neurologic diseases

  • Have a head injury

  • Have a brain tumor

  • Prior cranial surgery

  • Psychological disorder or mental problem

  • Previous stroke

  • Aphasia and apraxia

  • Upper extremity amputation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Abant Izzet Baysal University Faculty of Health Science Bolu Merkez Turkey 14100

Sponsors and Collaborators

  • Abant Izzet Baysal University

Investigators

  • Principal Investigator: Ramazan Kurul, Ph.D, Abant Izzet Baysal University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ramazan KURUL, Assistant Professor, Abant Izzet Baysal University
ClinicalTrials.gov Identifier:
NCT06152328
Other Study ID Numbers:
  • AIBU-FTR-BENLI-004
First Posted:
Nov 30, 2023
Last Update Posted:
Nov 30, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ramazan KURUL, Assistant Professor, Abant Izzet Baysal University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2023