NCT06244459

Brief Summary

The aim of the study is to investigate the applicability of virtual reality-mediated functional status assessment of patients diagnosed with stroke. Remote assessment of patients and remote rehabilitation (tele-rehabilitation) has an increasing application area in individuals with chronic neurological diseases. In this study, it was aimed to evaluate the upper extremity and balance functions of stroke patients with the developed software.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

January 20, 2024

Last Update Submit

April 16, 2025

Conditions

Keywords

virtual realityassessment

Outcome Measures

Primary Outcomes (3)

  • Box and Block Test

    The Box and Block Test measures unilateral gross manual dexterity. It is calculated how many cubes the patient moves between the compartments in 1 minute with both hands separately.

    1 day

  • 360 degree rotation test

    It is a useful and practical test to evaluate the balance functions of patients. It is calculated how many seconds it takes the patient to complete one full round.

    1 day

  • 5 times Squat Test

    It is performed to evaluate the balance and lower extremity functions of the patients, and the number of seconds it takes to squat 5 times is calculated.

    1 day

Study Arms (1)

Hemiplegia Group

EXPERIMENTAL

Participants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality.

Other: VR Assessment Tool

Interventions

Participants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality.

Hemiplegia Group

Eligibility Criteria

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

You may qualify if:

  • To be between the ages of 18-65,
  • History of stroke
  • Accept to participate in the study,

You may not qualify if:

  • Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurological deficit,
  • Uncontrolled hypertension, diabetes, cardiovascular disease etc.
  • Cognitive impairment causing difficulty in performing simple commands
  • Epilepsy
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmet Kıvanç Menekşeoğlu

Istanbul, 34015, Turkey (Türkiye)

Location

Related Publications (3)

  • Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.

  • Mong Y, Teo TW, Ng SS. 5-repetition sit-to-stand test in subjects with chronic stroke: reliability and validity. Arch Phys Med Rehabil. 2010 Mar;91(3):407-13. doi: 10.1016/j.apmr.2009.10.030.

  • Dite W, Temple VA. Development of a clinical measure of turning for older adults. Am J Phys Med Rehabil. 2002 Nov;81(11):857-66; quiz 867-8. doi: 10.1097/00002060-200211000-00010.

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmet Menekseoglu, MD

    Kanuni Sultan Suleyman Research and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Participants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2024

First Posted

February 6, 2024

Study Start

February 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

April 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

The data obtained as a result of the study will be used within the scope of academic study by protecting the personal information of the participants.

Locations