Mild Cognitive ImpairmentNCT06500650
The Effect of Vırtual Reality Application ın Elderly People With Mild Cognitive Impairment
A study testing Person-centred Occupational Therapy Intervention in people with Mild Cognitive Impairment, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the effect of virtual reality application on visual skills, perceived occupational performance and satisfaction in elderly individuals with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Person-centred Occupational Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 2 Jun 2024
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Being between 65-75 years of age
- Receiving a diagnosis of MCI according to DSM-5
- Being able to read and write
- Ability to understand and follow verbal instructions
- Not having auditory, visual and physical problems that may affect rehabilitation practice and communication
Who cannot join
- Having a chronic disease that may affect cognitive function
- Participation in any rehabilitation programme (physiotherapy, speech therapy, psychotherapy, etc.) during the study period
- Not being able to participate regularly in the intervention programme during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vırtual Reality Application on Visual Skills, Perceived Occupational Performance And Satisfaction ın Elderly People With Mild Cognitive Impairment: A Randomised Controlled Trial
This study was conducted to investigate the effect of virtual reality application on visual skills, perceived occupational performance and satisfaction in elderly individuals with mild cognitive impairment. This study was designed according to the CONSORT statement, which provides a standard method for randomised controlled trial (RCT) design. The study was approved by the Local Ethics Committee. Written informed consent was obtained from all participants before the study.
Read the detailed description
This study is a single-centre randomised controlled trial involving elderly individuals with mild cognitive impairment in Turkey. The research protocol was approved by the local ethics committee prior to the study. All participants gave written informed consent. This study was designed according to the CONSORT statement, which provides a standardised method for randomised controlled trial (RCT) design.
Participants: For the study, 60 elderly individuals with a diagnosis of HBB were evaluated. Fifty individuals who completed the assessment and met the inclusion/exclusion criteria were included in the study. A virtual reality intervention group (n=25) and a person-centred occupational therapy intervention group (n=25) were formed with the online randomisation application available at https://www.randomizer.org/ by randomly numbering from 1 to 50 with simple random sampling method. Two participants from the person-centred occupational therapy intervention group were excluded from the study because they did not regularly participate in the intervention programme. The study was completed with 48 participants.
Data were analysed with Statistical Package for the Social Sciences (SPSS) version 28.0 statistical package programme. The conformity of the data to normal distribution was tested by Shapiro-Wilk test. Independent Intergroup t test was used to compare normally distributed variables in two independent groups, and Mann Whitney U test was used to compare non-normally distributed variables in two independent groups. As descriptive statistics, mean (±) and standard deviation (X ± SD) values were given for numerical variables and number (n) and percentage (%) values were given for categorical variables.
Multivariate analysis of variance (MANOVA) was used to evaluate the effectiveness of the interventions. It was seen that the prerequisites before MANOVA were met. MANOVA is used to test whether groups formed according to one or more factors show a difference in terms of more than one dependent variable. MANOVA is a powerful multivariate statistic used in experimental research. The use of MANOVA is appropriate when there is a relationship between dependent variables. In this study, Box and Leveni tests, which are the test statistics produced by MANOVA to evaluate the differences between groups, were used to analyse the differences between groups. In the statistical analyses, the significance level was accepted as .05.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Person-centred Occupational Therapy Intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centred Occupational Therapy InterventionBehavioural
Person-centred Occupational Therapy Intervention
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Intervention Group | Experimental | Virtual reality application and person-centered occupational therapy intervention were applied to the virtual reality intervention group. VR intervention was implemented in a 30 m2 virtual reality unit using a PC Microsoft Kinect and a screen (50" flat LED screen TV) located approximately 1.5 meters away. Kinect can monitor the client's movements in the VR environment in real time by displaying them on the screen. In our study, before starting VR interventions, suitable games for intervention were determined by analyzing which skills each game required and which skills it could develop. Before starting the VR intervention, clients were informed about the games and shown how to play them. Receives: Behavioral: Person-centred Occupational Therapy Intervention |
| Person-centred Occupational Therapy Intervention Group | Experimental | Person-centered occupational therapy intervention was applied to both groups according to the evaluation results. The basis of the person-centered occupational therapy intervention is the activities and visual skills that the participants stated in the COPM in the first evaluation and in which they had problems. Person-centered occupational therapy intervention consists of 5 stages: (1) person-centered goal setting, (2) creation of the therapy plan, (3) implementation of interventions, (4) evaluation of results, and (5) obtaining feedback. Receives: Behavioral: Person-centred Occupational Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Perception Test Independent of Motor Skills-4
The Motor Skill Independent Visual Perception Test-4 (MVPT-4) is a standardised test (α= 0.80, r=0.53) that assesses visual perception skills without requiring motor or verbal responses. The test consists of 45 items and takes approximately 20 minutes. 4- It can be used in 85+ people. MVPT-4 evaluates five categories of visual perception: visual discrimination, spatial relationship, visual memory, shape-ground, visual proximity. The test result is determined by subtracting the total number of 45. The higher the score, the better the visual perception skill is interpreted.
Measured: 30 minutes
Canadian Occupational Performance Measure(COPM)
COPM, which is most frequently used among occupational therapists, is a standardised measurement tool used to determine the individual's activity performance problems and to measure performance satisfaction. In the COPM, which is a semi-structured interview, individuals evaluate their activity preferences with performance and satisfaction scores given by themselves. Individuals are asked about their activity performance problems and concerns about 3 areas including self-care, productivity and leisure time activities. Up to three problems can be identified in each activity area (self-care, productivity, leisure). Performance and satisfaction scores are again determined by the individual between 1 and 10 points. The Turkish adaptation, validity and reliability study of the COPM was conducted by Torpil et al.
Measured: 30 minutes
Secondary outcomes (1)
Trail Making Test(TMT)
In form A; before the test starts, the numbers from 1 to 8 on the sample application form of the test are asked to be drawn in a way to be followed in order. After the trial test, the participants are asked to combine the numbers from 1 to 25 against time and the time is recorded in seconds when the test is completed. The Turkish validation of the TMT-A was performed by Cangöz et al. The ICC values of the test were found to be 0.78 and 0.99, respectively. In form B, the test consists of a series of circles numbered between 1-13 and circles with letters from A to L on a piece of paper. The person is asked to proceed by matching the numbers and letters from number to letter. The time (in seconds) to complete the combination constitutes the score for the test. The ICC values of the test, which was validated in Turkish by Cangöz et al. were found to be 0.73 and 0.93, respectively.
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Jul 2023
- Primary completion1 Jun 2024
- Study completion2 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkan Torpil, PhD, Saglik Bilimleri Universitesi
- Investigators
- Berkan Torpil, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500650
- Sponsor's protocol ID
- 2023/163
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vırtual Reality Application on Visual Skills, Perceived Occupational Performance And Satisfaction ın Elderly People With Mild Cognitive Impairment: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06500650
- Acronym / sponsor ID
- 2023/163
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 2 Jun 2024 (actual)
- First posted
- 15 Jul 2024 (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.
This study was conducted to investigate the effect of virtual reality application on visual skills, perceived occupational performance and satisfaction in elderly individuals with mild cognitive impairment. This study was designed according to the CONSORT statement, which provides a standard method for randomised controlled trial (RCT) design. The study was approved by the Local Ethics Committee. Written informed consent was obtained from all participants before the study.
Detailed description
This study is a single-centre randomised controlled trial involving elderly individuals with mild cognitive impairment in Turkey. The research protocol was approved by the local ethics committee prior to the study. All participants gave written informed consent. This study was designed according to the CONSORT statement, which provides a standardised method for randomised controlled trial (RCT) design.
Participants: For the study, 60 elderly individuals with a diagnosis of HBB were evaluated. Fifty individuals who completed the assessment and met the inclusion/exclusion criteria were included in the study. A virtual reality intervention group (n=25) and a person-centred occupational therapy intervention group (n=25) were formed with the online randomisation application available at https://www.randomizer.org/ by randomly numbering from 1 to 50 with simple random sampling method. Two participants from the person-centred occupational therapy intervention group were excluded from the study because they did not regularly participate in the intervention programme. The study was completed with 48 participants.
Data were analysed with Statistical Package for the Social Sciences (SPSS) version 28.0 statistical package programme. The conformity of the data to normal distribution was tested by Shapiro-Wilk test. Independent Intergroup t test was used to compare normally distributed variables in two independent groups, and Mann Whitney U test was used to compare non-normally distributed variables in two independent groups. As descriptive statistics, mean (±) and standard deviation (X ± SD) values were given for numerical variables and number (n) and percentage (%) values were given for categorical variables.
Multivariate analysis of variance (MANOVA) was used to evaluate the effectiveness of the interventions. It was seen that the prerequisites before MANOVA were met. MANOVA is used to test whether groups formed according to one or more factors show a difference in terms of more than one dependent variable. MANOVA is a powerful multivariate statistic used in experimental research. The use of MANOVA is appropriate when there is a relationship between dependent variables. In this study, Box and Leveni tests, which are the test statistics produced by MANOVA to evaluate the differences between groups, were used to analyse the differences between groups. In the statistical analyses, the significance level was accepted as .05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention Group | Experimental | Behavioral: Person-centred Occupational Therapy InterventionVirtual reality application and person-centered occupational therapy intervention were applied to the virtual reality intervention group. VR intervention was implemented in a 30 m2 virtual reality unit using a PC Microsoft Kinect and a screen (50" flat LED screen TV) located approximately 1.5 meters away. Kinect can monitor the client's movements in the VR environment in real time by displaying them on the screen. In our study, before starting VR interventions, suitable games for intervention were determined by analyzing which skills each game required and which skills it could develop. Before starting the VR intervention, clients were informed about the games and shown how to play them. |
| Person-centred Occupational Therapy Intervention Group | Experimental | Behavioral: Person-centred Occupational Therapy InterventionPerson-centered occupational therapy intervention was applied to both groups according to the evaluation results. The basis of the person-centered occupational therapy intervention is the activities and visual skills that the participants stated in the COPM in the first evaluation and in which they had problems. Person-centered occupational therapy intervention consists of 5 stages: (1) person-centered goal setting, (2) creation of the therapy plan, (3) implementation of interventions, (4) evaluation of results, and (5) obtaining feedback. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Being between 65-75 years of age
- Receiving a diagnosis of MCI according to DSM-5
- Being able to read and write
- Ability to understand and follow verbal instructions
- Not having auditory, visual and physical problems that may affect rehabilitation practice and communication
Key exclusion criteria (3 listed)
- Having a chronic disease that may affect cognitive function
- Participation in any rehabilitation programme (physiotherapy, speech therapy, psychotherapy, etc.) during the study period
- Not being able to participate regularly in the intervention programme during the study period
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 |
|---|---|---|
| Person-centred Occupational Therapy InterventionPerson-centred Occupational Therapy Intervention | Behavioural | Person-centred Occupational Therapy Intervention Group, Virtual Reality Intervention Group |
Primary outcome
Visual Perception Test Independent of Motor Skills-4
Time frame: 30 minutes
The Motor Skill Independent Visual Perception Test-4 (MVPT-4) is a standardised test (α= 0.80, r=0.53) that assesses visual perception skills without requiring motor or verbal responses. The test consists of 45 items and takes approximately 20 minutes. 4- It can be used in 85+ people. MVPT-4 evaluates five categories of visual perception: visual discrimination, spatial relationship, visual memory, shape-ground, visual proximity. The test result is determined by subtracting the total number of 45. The higher the score, the better the visual perception skill is interpreted.
Canadian Occupational Performance Measure(COPM)
Time frame: 30 minutes
COPM, which is most frequently used among occupational therapists, is a standardised measurement tool used to determine the individual's activity performance problems and to measure performance satisfaction. In the COPM, which is a semi-structured interview, individuals evaluate their activity preferences with performance and satisfaction scores given by themselves. Individuals are asked about their activity performance problems and concerns about 3 areas including self-care, productivity and leisure time activities. Up to three problems can be identified in each activity area (self-care, productivity, leisure). Performance and satisfaction scores are again determined by the individual between 1 and 10 points. The Turkish adaptation, validity and reliability study of the COPM was conducted by Torpil et al.
1 secondary outcome
Trail Making Test(TMT)
Time frame: 25 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Berkan Torpil, PhD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centred Occupational Therapy Intervention in people with Mild Cognitive Impairment, run by Saglik Bilimleri Universitesi 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 5 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: finished, as of the sponsor's last update on 15 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Perception Test Independent of Motor Skills-4 (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 15 Jul 2024.