The Effect of Vırtual Reality Application ın Elderly People With Mild Cognitive Impairment

NCT ID: NCT06500650

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-06-02

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Virtual Reality Intervention Group

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.

Group Type: EXPERIMENTAL

Person-centred Occupational Therapy Intervention

Intervention Type: BEHAVIORAL

Person-centred Occupational Therapy Intervention

Person-centred Occupational Therapy Intervention Group

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.

Group Type: EXPERIMENTAL

Person-centred Occupational Therapy Intervention

Intervention Type: BEHAVIORAL

Person-centred Occupational Therapy Intervention

Interventions

Person-centred Occupational Therapy Intervention

Person-centred Occupational Therapy Intervention

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Berkan Torpil, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berkan Torpil, PhD

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

University of Health Sciences

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/163

Identifier Type: -

Identifier Source: org_study_id