NCT06500650

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

July 8, 2024

Last Update Submit

July 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    30 minutes

Secondary Outcomes (1)

  • Trail Making Test(TMT)

    25 minutes

Study Arms (2)

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.

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.

Behavioral: Person-centred Occupational Therapy Intervention

Interventions

Person-centred Occupational Therapy Intervention

Person-centred Occupational Therapy Intervention GroupVirtual Reality Intervention Group

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Berkan Torpil, PhD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 15, 2024

Study Start

July 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 2, 2024

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations