NCT05624892

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

December 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

October 13, 2022

Last Update Submit

November 14, 2022

Conditions

Keywords

StrokeHome CareMirror TherapyVirtual RealityNursing

Outcome Measures

Primary Outcomes (1)

  • 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.

    One month

Secondary Outcomes (1)

  • Collection of the final test

    Three monts

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Diagnostic Test: Mirror Therapy with Virtual Reality Application

Control Group

NO INTERVENTION

Application of classical mirror therapy to the control group

Interventions

Researchers will apply Mirror Therapy with Virtual Reality Application to increase individuals' quality of life and motor sense gains.

Experimental Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • To reside outside the borders of Erzurum province
  • Be under the age of 18
  • In Brunnstrom staging, the upper extremity is below Stage 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Muhammet Ali AYDIN, Ph. D

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: In the study, 60 individuals, including 1 experimental and 1 control group, were included in the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 13, 2022

First Posted

November 22, 2022

Study Start

December 1, 2021

Primary Completion

May 30, 2022

Study Completion

December 30, 2022

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations