NCT06152328

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
1mo left

Started Apr 2024

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Apr 2024Jun 2026

First Submitted

Initial submission to the registry

November 22, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

2.1 years

First QC Date

November 22, 2023

Last Update Submit

June 19, 2025

Conditions

Keywords

RehabilitationVirtual Reality Immersion TherapyMirror Movement Therapy

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment

    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.

    8 Weeks

Secondary Outcomes (5)

  • Evaluation of Cortical Activation with EEG

    8 Weeks

  • Motor Activity Log-28

    8 Weeks

  • Simulator Sickness Questionnaire

    8 Weeks

  • System Usability Scale

    8 Weeks

  • Stroke-Specific Quality of Life Scale

    8 Weeks

Study Arms (2)

VR group

ACTIVE COMPARATOR

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 therapyOther: Conventional treatment

Control group

ACTIVE COMPARATOR

In addition to mirror therapy, 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. In addition, a virtual environment monitoring session will be conducted in non-interactive virtual environments for 10 minutes after their treatment.

Other: Conventional treatmentOther: Mirror therapyOther: Placebo virtual reality

Interventions

Mirror therapy-based games will be played for 30 minutes every day for eight weeks, three days a week, for the VR group.

VR group

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

Control groupVR group

In conventional mirror therapy, the unaffected extremities of the individuals will be positioned outside the mirror, while the affected extremities will be placed inside the mirror so that the patient cannot see them. In this way, the image of the intact hand will be transferred to the affected side and activities will be performed three days a week for eight weeks.

Control group

For 8 weeks, watching the uninteractive virtual environment for 10 minutes

Control group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University Faculty of Health Science

Bolu, Merkez, 14100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

StrokeParesis

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Ramazan Kurul, Ph.D

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Enes Tayyip Benli, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The assessor will not know which group the patients are in. Participants in control group will experience a virtual reality environment without any interaction
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups parallel design randomized controlled prospective rehabilitation study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 22, 2023

First Posted

November 30, 2023

Study Start

April 1, 2024

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations