Stroke SyndromeNCT05624892
The Effect of Mirror Therapy With Virtual Reality Application on Motor-Sense Acquisition and Quality of Live in Home Care of Stroke Patients
A study testing Mirror Therapy with Virtual Reality Application in people with Stroke Syndrome, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke Syndrome
- What is being tested?
- Mirror Therapy with Virtual Reality Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- Not having a vertigo problem
- Not being diagnosed with epilepsy
- In Brunnstrom staging, Upper extremity Stage 2 and above
Who cannot join
- To reside outside the borders of Erzurum province
- Be under the age of 18
- In Brunnstrom staging, the upper extremity is below Stage 2
Trial locations and contacts
1 site in 1 country.
About this study
: 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.
- Conditions
- Stroke Syndrome
- Being tested
- Mirror Therapy with Virtual Reality Application
- Keywords
- Stroke, Home Care, Mirror Therapy, Virtual Reality, Nursing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror Therapy with Virtual Reality ApplicationDiagnostic test
Researchers will apply Mirror Therapy with Virtual Reality Application to increase individuals' quality of life and motor sense gains.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Application of mirror therapy to the experimental group with virtual reality application Receives: Diagnostic Test: Mirror Therapy with Virtual Reality Application |
| Control Group | No intervention | Application of classical mirror therapy to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month
Secondary outcomes (1)
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.
Measured: Three monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Dec 2021
- Primary completion30 May 2022
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SyndromeStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, 60 individuals, including 1 experimental and 1 control group, were included in the study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Ali AYDIN, Ataturk University
- Investigators
- Muhammet Ali AYDIN, Ph. D, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624892
- Sponsor's protocol ID
- ATAUNI-001
- Status last verified
- Nov 2022
- First submitted
- 13 Oct 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05624892
- Acronym / sponsor ID
- ATAUNI-001
- Conditions
- Stroke Syndrome
- Keywords
- Stroke, Home Care, Mirror Therapy, Virtual Reality, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In the study, 60 individuals, including 1 experimental and 1 control group, were included in the study.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Diagnostic Test: Mirror Therapy with Virtual Reality ApplicationApplication of mirror therapy to the experimental group with virtual reality application |
| Control Group | No intervention | –Application of classical mirror therapy to the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (3 listed)
- To reside outside the borders of Erzurum province
- Be under the age of 18
- In Brunnstrom staging, the upper extremity is below Stage 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror Therapy with Virtual Reality ApplicationResearchers will apply Mirror Therapy with Virtual Reality Application to increase individuals' quality of life and motor sense gains. | Diagnostic test | Experimental Group |
Primary outcome
Rehabilitation of the experimental and control groups for 30 minutes 3 days a week for 4 weeks
Time frame: One month
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.
1 secondary outcome
Collection of the final test
Time frame: Three monts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammet Ali AYDIN, Ph. D principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy with Virtual Reality Application in people with Stroke Syndrome, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehabilitation of the experimental and control groups for 30 minutes 3 days a week for 4 weeks (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.