Clinical trial NCT06500650: The Effect of Vırtual Reality Application ın Elderly People With Mild Cognitive Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Visual Perception Test Independent of Motor Skills-4
timeFrame: 30 minutes
measure: Canadian Occupational Performance Measure(COPM)
timeFrame: 30 minutes
Secondary outcomes:
measure: Trail Making Test(TMT)
timeFrame: 25 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Berkan Torpil, PhD
role: PRINCIPAL_INVESTIGATOR
References: