NCT07693413

Brief Summary

The aim of this study is to investigate the effectiveness of mixed reality (MR)-based rehabilitation applications in improving motor functions, trunk stability, and upper extremity performance in stroke patients. The use of mixed reality technology in addition to traditional rehabilitation methods provides individuals with an interactive and motivating rehabilitation environment that mimics real-life activities. The study aims to increase functional independence, improve motor skills and trunk stability, enhance upper extremity functions, facilitate return to daily living activities, increase adaptation and motivation to the rehabilitation process, and provide a repeatable, safe, and patient-centered exercise environment in stroke patients. This thesis aims to contribute to both clinical physiotherapy practice and the literature by evaluating the applicability of mixed reality technology, a patient-centered and innovative rehabilitation approach, as a treatment option in neurological rehabilitation. The study's objective in improving upper extremity function is to make the individual less dependent on others while performing daily living activities, to instill a sense of self-sufficiency, and to enhance existing skills to make them more functional.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
Last Updated

July 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 27, 2026

Last Update Submit

July 3, 2026

Conditions

Keywords

strokerehabilitationvirtual realityupper extremity

Outcome Measures

Primary Outcomes (1)

  • Modified Box and Block Test - mBBT

    The individual performs this test with both their dominant and non-dominant hand. mBBT reflects a direct assessment of individuals' upper extremity functional performance based on the number of blocks transferred from one compartment to the other within 30 seconds. At the end of the time period, the number of blocks transferred to the opposite compartment is recorded.

    Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

Secondary Outcomes (6)

  • L-Shape Test

    Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

  • Action Research Arm Test -ARAT

    Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

  • İmpairment Scale - TIS

    Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

  • BlazePod

    Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

  • Specific Quality of Life Scale (SS-QOL)

    Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

  • +1 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Control group, receiving traditional treatment

Other: Traditional therapy

Intervention group

ACTIVE COMPARATOR

Intervention group, receiving virtual reality treatment

Other: virtual reality

Interventions

The treatment will last 8 weeks, 3 days a week, with each session lasting 30 minutes. Participants will receive traditional physiotherapy treatment, including upper extremity strengthening, motor skills exercises, and balance exercises.

Control group

The treatment will last 8 weeks, 3 days a week, with each session lasting 30 minutes. Participants will be playing Reach VR within the Meta Quest 3 using the eye.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Individuals aged 18-65 who have experienced a stroke.
  • At least 6 months must have passed since the stroke.
  • FIM independence scale score of 50 or higher.
  • Fugl-Meyer Upper Extremity Assessment (FMA) score between 23-66.
  • Mini Mental Test score above 24.

You may not qualify if:

  • Presence of current epileptic seizures.
  • Upper extremity spasticity 3-4.
  • Visual or hearing loss that would affect the study.
  • Individuals who have experienced multiple strokes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu Univercity

Gaziantep, Gaziantep, 27000, Turkey (Türkiye)

Location

Related Publications (2)

  • Thijs L, Voets E, Denissen S, Mehrholz J, Elsner B, Lemmens R, Verheyden GS. Trunk training following stroke. Cochrane Database Syst Rev. 2023 Mar 2;3(3):CD013712. doi: 10.1002/14651858.CD013712.pub2.

  • Deathe AB, Miller WC. The L test of functional mobility: measurement properties of a modified version of the timed "up & go" test designed for people with lower-limb amputations. Phys Ther. 2005 Jul;85(7):626-35.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • KEZBAN YİĞİTER, PROFESSOR

    HASAN KALYONCU UNIVERCITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group was a control group receiving traditional treatment, and the other group was an intervention group receiving virtual reality treatment. A total of two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 27, 2026

First Posted

July 9, 2026

Study Start

January 1, 2026

Primary Completion

March 1, 2026

Study Completion

May 30, 2026

Last Updated

July 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations