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The Effect of Mirror Therapy With Virtual Reality Application on Motor-Sense Acquisition and Quality of Live in Home Care of Stroke Patients

Primary Purpose

Stroke Syndrome

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mirror Therapy with Virtual Reality Application
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke Syndrome focused on measuring Stroke, Home Care, Mirror Therapy, Virtual Reality, Nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being literate, Be over 18 years old, Having sufficient communication skills to be able to answer verbal and written questions and follow instructions, To have applied to benefit from home care services, Having been diagnosed with stroke and being at least 6 days old, Not having advanced vision problems, Not having a vertigo problem Not being diagnosed with epilepsy In Brunnstrom staging, Upper extremity Stage 2 and above Exclusion Criteria: To reside outside the borders of Erzurum province Be under the age of 18 In Brunnstrom staging, the upper extremity is below Stage 2

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

Application of mirror therapy to the experimental group with virtual reality application

Application of classical mirror therapy to the control group

Outcomes

Primary Outcome Measures

Rehabilitation of the experimental and control groups for 30 minutes 3 days a week for 4 weeks
Individuals in the experimental and control groups were evaluated with the "Brunnstrom Staging" and the "SF-36 Quality of Life Scale". The Brunnstrom Staging" and the "SF-36 Quality of Life Scale consists of 8 sub-dimensions. It is expected that the average score will increase in all sub-dimensions of the scale. Higher scores indicate that physical function, social functionality, mental health, energy/vitality and general health sub-dimensions increase. Similarly, higher scores indicate a decrease in physical role difficulty, emotional role difficulty and pain.

Secondary Outcome Measures

Collection of the final test
The final test for individuals in the experimental and control groups were evaluated with the "Brunnstrom Staging" and the "SF-36 Quality of Life Scale". The experimental group received mirror therapy with virtual reality application, and the control group had classical mirror therapy. The Brunnstrom Staging" and the "SF-36 Quality of Life Scale consists of 8 sub-dimensions. It is expected that the average score will increase in all sub-dimensions of the scale. Higher scores indicate that physical function, social functionality, mental health, energy/vitality and general health sub-dimensions increase. Similarly, higher scores indicate a decrease in physical role difficulty, emotional role difficulty and pain.

Full Information

First Posted
October 13, 2022
Last Updated
November 14, 2022
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05624892
Brief Title
The Effect of Mirror Therapy With Virtual Reality Application on Motor-Sense Acquisition and Quality of Live in Home Care of Stroke Patients
Official Title
The Effect of Mirror Therapy With Virtual Reality Application on Motor-Sense Acquisition and Quality of Live in Home Care of Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
: Aim: Stroke is increasing day by day in our country as in the world. Early rehabilitation after stroke accelerates motor-sensory gains of individuals. This also increases the quality of life. Although there are studies on post-stroke rehabilitation in our country, rehabilitation applications with virtual reality application are very limited. For this reason, the research was carried out to determine the effect of home therapy with virtual reality application on motor-sensory gains and quality of life after stroke. Material and method: The research was conducted as a randomized controlled experimental study. The universe of the research; Between December 2021 and May 2022, individuals who met the criteria for inclusion in the study who applied for home care to Erzurum Atatürk University Health Application and Research Center Physical Therapy Unit with the diagnosis of loss of movement in the upper extremity after stroke were formed. The sample size for the research was determined by power analysis. In the power analysis, it was determined that a total of 52 people should be reached in order to reach the 95% confidence level at the 0.05 significance level and 80% power at the p<0.05 significance level. Considering that there may be data losses in the study, it was decided to reach 60 people, 15% more than the sample. "Descriptive Feature Form", "Brunnstrom Staging" and "SF-36 Quality of Life Scale" were used to collect data.In the analysis of data; percentile distribution, chi-square, Fisher-Freeman- Halton Exact test, t-test in independent groups, Repeated Measures ANOVA Test, Friedman Test, One Way ANOVA test, Kruskall Wallis test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) were used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Syndrome
Keywords
Stroke, Home Care, Mirror Therapy, Virtual Reality, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In the study, 60 individuals, including 1 experimental and 1 control group, were included in the study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Application of mirror therapy to the experimental group with virtual reality application
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Application of classical mirror therapy to the control group
Intervention Type
Diagnostic Test
Intervention Name(s)
Mirror Therapy with Virtual Reality Application
Intervention Description
Researchers will apply Mirror Therapy with Virtual Reality Application to increase individuals' quality of life and motor sense gains.
Primary Outcome Measure Information:
Title
Rehabilitation of the experimental and control groups for 30 minutes 3 days a week for 4 weeks
Description
Individuals in the experimental and control groups were evaluated with the "Brunnstrom Staging" and the "SF-36 Quality of Life Scale". The Brunnstrom Staging" and the "SF-36 Quality of Life Scale consists of 8 sub-dimensions. It is expected that the average score will increase in all sub-dimensions of the scale. Higher scores indicate that physical function, social functionality, mental health, energy/vitality and general health sub-dimensions increase. Similarly, higher scores indicate a decrease in physical role difficulty, emotional role difficulty and pain.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Collection of the final test
Description
The final test for individuals in the experimental and control groups were evaluated with the "Brunnstrom Staging" and the "SF-36 Quality of Life Scale". The experimental group received mirror therapy with virtual reality application, and the control group had classical mirror therapy. The Brunnstrom Staging" and the "SF-36 Quality of Life Scale consists of 8 sub-dimensions. It is expected that the average score will increase in all sub-dimensions of the scale. Higher scores indicate that physical function, social functionality, mental health, energy/vitality and general health sub-dimensions increase. Similarly, higher scores indicate a decrease in physical role difficulty, emotional role difficulty and pain.
Time Frame
Three monts

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being literate, Be over 18 years old, Having sufficient communication skills to be able to answer verbal and written questions and follow instructions, To have applied to benefit from home care services, Having been diagnosed with stroke and being at least 6 days old, Not having advanced vision problems, Not having a vertigo problem Not being diagnosed with epilepsy In Brunnstrom staging, Upper extremity Stage 2 and above Exclusion Criteria: To reside outside the borders of Erzurum province Be under the age of 18 In Brunnstrom staging, the upper extremity is below Stage 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammet Ali AYDIN, Ph. D
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ataturk University
City
Erzurum
ZIP/Postal Code
25030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Effect of Mirror Therapy With Virtual Reality Application on Motor-Sense Acquisition and Quality of Live in Home Care of Stroke Patients

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