NCT07018336

Brief Summary

Upper extremity impairment in hemiplegic patients significantly impacts daily activities and reduces quality of life. Although traditional rehabilitation methods can help, some patients experience limited progress. Recently, modern techniques such as mirror therapy and virtual reality (VR) have emerged, demonstrating promising results in motor skill improvement. This study aims to directly compare the acute effects of mirror therapy and VR therapy on upper limb motor function in hemiplegic patients. Forty-two participants aged 18-75 with hemiplegia due to stroke (6-12 months post-stroke) will be randomly assigned to either mirror therapy or VR therapy. The evaluation includes motor function (Fugl-Meyer Assessment), spasticity (Modified Ashworth Scale), activities of daily living (Barthel Index), fine motor skills (Box and Block Test), proprioception, and reaction time. The goal is to identify the effectiveness of the mirror therapy and VR therapy on motor function, spasticity control, proprioception, daily activity performance, and reaction times, contributing valuable insights to clinical rehabilitation practices.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2025

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 Progress86%
May 2025Jul 2026

First Submitted

Initial submission to the registry

May 16, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

May 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

May 16, 2025

Last Update Submit

February 26, 2026

Conditions

Keywords

StrokeSpasticityProprioceptionReaction Time

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

    The Fugl-Meyer Assessment is a standardized and widely used tool designed to evaluate motor function, balance, sensation, and joint functioning in individuals with post-stroke hemiplegia. In this study, only the upper extremity motor domain will be used, which includes evaluation of movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. The assessment is scored on a 3-point ordinal scale: 0 (cannot perform), 1 (performs partially), and 2 (performs fully), with a maximum score of 66 indicating better motor recovery. Participants are seated or lying in a comfortable position during the test, and each movement is explained and demonstrated. The researcher scores the quality and completion of each movement. The FMA-UE is a valid and reliable measure of motor function and is widely used in stroke rehabilitation research

    Day 1

  • Box and Block Test (BBT)

    The Box and Block Test (BBT) is a standardized assessment of unilateral gross manual dexterity. Participants are instructed to transfer as many wooden blocks as possible from one compartment of a box to the other within 60 seconds using one hand. The number of successfully transferred blocks is recorded as the score. The test is widely recognized for its simplicity, reliability, and sensitivity in detecting changes in motor function, especially in post-stroke patients. In this study, the BBT will be used to evaluate changes in upper extremity motor performance and coordination immediately before and after the intervention session.

    Day 1

Secondary Outcomes (5)

  • Modified Ashworth Scale (MAS)

    Day 1

  • joint Position Sense Test (Proprioception Assessment)

    Day 1

  • Simple Reaction Time (SRT) with BlazePod

    Day 1

  • Global Rating of Change (GRC) scale

    Day 1

  • Barthel Index (Activities of Daily Living - ADL)

    Day 1

Study Arms (2)

Mirror Therapy

EXPERIMENTAL

Participants will receive a single 30-minute session of mirror therapy applied to the affected upper extremity. The therapy will involve performing functional upper limb movements while viewing the mirror reflection of the unaffected limb to create the visual illusion of symmetrical bilateral movement.

Other: Mirror Therapy

Virtual Reality (VR) Therapy

EXPERIMENTAL

Participants in this group will receive a single 30-minute session of virtual reality-based upper extremity rehabilitation using a Meta Quest 2 head-mounted display. The intervention will consist of task-oriented, interactive exercises targeting shoulder, elbow, wrist, and hand movements. The session will be conducted under supervision to ensure safety and proper task performance.

Device: Virtual Reality (VR) Therapy

Interventions

Mirror therapy will be applied to the affected upper extremity by placing a mirror in the midsagittal plane to reflect movements of the non-paretic limb, creating the visual illusion of symmetrical bilateral movement. Participants will perform task-specific functional movements of the hand and arm (e.g., grasping, wrist flexion, and extension) while focusing on the mirror image.

Mirror Therapy

Virtual reality therapy will be delivered using the Meta Quest 2 head-mounted display system. Participants will engage in interactive, task-specific upper extremity exercises designed to promote motor activation and functional movement of the affected limb through immersive visual feedback.

Virtual Reality (VR) Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemiplegic patients in need of upper extremity rehabilitation.
  • Having had a stroke 6 to 12 months prior to the study.
  • Being at least Stage 3 for the upper extremity according to the Brunnstrom motor recovery stages.
  • Age range: between 18 and 75 years.
  • Individuals who volunteer to participate in the study.
  • Individuals who are cognitively suitable for mirror therapy and virtual reality applications (a score of at least 24 on the Mini Mental State Examination)

You may not qualify if:

  • Patients with severe spasticity (score ≥ 3 on the Modified Ashworth Scale)
  • Individuals with secondary neurological conditions (e.g., Parkinson's disease, multiple sclerosis).
  • Individuals diagnosed with vestibular dysfunction (as virtual reality equipment may cause issues like nausea or dizziness).
  • Individuals with communication issues, such as hearing or vision loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstinye Üniversite Hastanesi Medical Park Gaziosmanpaşa

Istanbul, Gaziosmanpaşa, 34065, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

HemiplegiaStrokeMuscle Spasticity

Interventions

Mirror Movement TherapyTherapeutics

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitation

Study Officials

  • Çiçek Günday, Asst. Prof.

    Istinye University, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR
  • Maysaa Hamdy Othman Ibrahim, Physiotherapist

    Istinye University, Department of Physiotherapy and Rehabilitation

    STUDY DIRECTOR

Central Study Contacts

Çiçek Günday, Asst. Prof.

CONTACT

Maysaa Hamdy Othman Ibrahim, Physiotherapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

May 16, 2025

First Posted

June 12, 2025

Study Start

May 30, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations