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Clinical Trials/NCT06380894
NCT06380894
Completed
Not Applicable

Virtual Reality Cognitive Training for Mild Cognitive Impairment - A Pilot Feasibility Study

Changi General Hospital1 site in 1 country20 target enrollmentJanuary 27, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Changi General Hospital
Enrollment
20
Locations
1
Primary Endpoint
Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study aims to assess the feasibility and efficacy of a 10-weekly multi-domain VRCT program on the cognitive function (i.e. attention, memory, and executive functioning) of older adults with MCI.

Detailed Description

This study employed a pilot feasibility parallel design approach. Participants were randomly assigned to either the VRCT intervention group or the active control group. The outcome assessor was blinded. Participants were recruited from outpatient clinics in Changi General Hospital, Singapore. They were referred by treating geriatricians and psycho-geriatricians.

Registry
clinicaltrials.gov
Start Date
January 27, 2021
End Date
January 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • aged 65-85
  • diagnosis of MCI by a clinician in accordance to Petersen's criteria
  • MMSE ≥ 23
  • ability to see and hear
  • ability to read and write in either English or Mandarin

Exclusion Criteria

  • diagnosed with a primary other neurocognitive disorder
  • diagnosed with major psychiatric illness such as major depressive disorder or anxiety disorder, severe visual or auditory impairment
  • diagnosed with serious medical illnesses including acute or severe asthma, severe or unstable cardiovascular disease, active gastric ulcer, severe liver disease or severe renal disease.

Outcomes

Primary Outcomes

Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11

Time Frame: Baseline and Week 11

The RBANS is a comprehensive neuropsychological battery that has been validated with local norms in Singapore. Its subtest of Digit Span measures attention. It is administered by trained clinical research coordinators and scored by neuropsychologists. Raw scores of the Digit Span subtest is compared.

Change from Baseline in Attention Performance on the Colour Trails Test 1 at Week 11

Time Frame: Baseline and Week 11

The Colour Trails Test 1 requires the respondent to connect circles in an ascending numbered sequence. Time taken to complete each part of the CTT is recorded in seconds.

Change from Baseline in Memory Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests at Week 11

Time Frame: Baseline and Week 11

The RBANS is a comprehensive neuropsychological battery that has been validated with local norms in Singapore. Its subtests of List Learning, List Recall and List Recognition measures verbal memory while Picture Copy and Picture Recall measures visual memory. It is administered by trained clinical research coordinators and scored by neuropsychologists. Raw scores of each subtests are compared.

Change from Baseline in Executive Function Performance on the Frontal Assessment Battery (FAB) at Week 11

Time Frame: Baseline and Week 11

The FAB is a short screening tests used to evaluate executive function. Its components consist of S-word generation, similarities, Luria's test, grasp reflex, and the Go-No-Go test. The sum of the sub-scores from each of the six components are added up to generate total score out of 18.

Change from Baseline in Executive Function Performance on the Colour Trails Test 2 at Week 11

Time Frame: Baseline and Week 11

The FAB is a short screening tests used to evaluate executive function. Its components consist of S-word generation, similarities, Luria's test, grasp reflex, and the Go-No-Go test. The sum of the sub-scores from each of the six components are added up to generate total score out of 18.

Study Sites (1)

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