NCT06575218

Brief Summary

Alzheimer's disease is the most common type of dementia, accounting for 50% of all cases. Advanced age is a significant risk factor for AD. Virtual Reality (VR) is an interactive video game technology that provides computer-generated environments that include physical activity and provide users with experiences similar to those in the real world. VR technology can be used for rehabilitation purposes in individuals with various orthopedic and neurological disorders due to its ability to enhance motor, cognitive learning and neural plasticity (1,2). The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 21, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 23, 2024

Last Update Submit

August 27, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Montreal cognitive assessment scale

    MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.

    12 weeks

  • Berg Balance Scale

    BBS measures static and dynamic balance in elderly individuals

    12 weeks

  • Time up and Go Test

    TUG test evaluates fall risk, mobility and physical performance in the elderly

    12 weeks

Study Arms (3)

Virtual reality training group

EXPERIMENTAL

It will be included in the virtual reality training program to be implemented with the Wii-fit console.

Other: Conventional exercise and cognitive exerciseOther: control

Conventional exercise and cognitive exercise group

EXPERIMENTAL

It will be included in the cognitive exercise program along with conventional balance exercises.

Device: Virtual reality trainingOther: control

Control group

NO INTERVENTION

no intervention

Interventions

Virtual reality training

Conventional exercise and cognitive exercise group

Conventional exercise and cognitive exercise

Virtual reality training group
controlOTHER

no intervention

Conventional exercise and cognitive exercise groupVirtual reality training group

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 55 years and older Diagnosed with AD according to DSM-IV diagnostic criteria by a neurologist, MOCA ≥ 16 Clinical Dementia Rating Scale \< 2

You may not qualify if:

  • Various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.) Clinically significant aphasia (must be able to understand the therapist's commands) Significant visual or sensory impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebru Akbuğa Koç

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Ebru Akbuga Koc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 28, 2024

Study Start

May 21, 2024

Primary Completion

August 31, 2024

Study Completion

September 6, 2024

Last Updated

August 30, 2024

Record last verified: 2024-08

Locations