- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05624892
The Effect of Mirror Therapy With Virtual Reality Application on Motor-Sense Acquisition and Quality of Live in Home Care of Stroke Patients
: 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Erzurum, Turkey, 25030
- Ataturk University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
Application of mirror therapy to the experimental group with virtual reality application
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Researchers will apply Mirror Therapy with Virtual Reality Application to increase individuals' quality of life and motor sense gains.
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No Intervention: Control Group
Application of classical mirror therapy to the control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rehabilitation of the experimental and control groups for 30 minutes 3 days a week for 4 weeks
Time Frame: One month
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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.
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One month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collection of the final test
Time Frame: Three monts
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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.
|
Three monts
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammet Ali AYDIN, Ph. D, Ataturk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATAUNI-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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