NCT04819126

Brief Summary

•This study was planned to investigate the effects of the Nintendo Wii virtual reality application on muscle strength and fall risk in individuals with AD. The aim of the present study is to investigate the effect of the virtual reality application on muscle strength and fall in individuals with Alzheimer' Dementia (AD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

March 10, 2021

Last Update Submit

March 25, 2021

Conditions

Keywords

Alzheimer's DementiaMuscle strengthFallVirtual reality

Outcome Measures

Primary Outcomes (3)

  • Age :mean or median age

    Age, Categorical: \>=65 years

    period of 6 weeks

  • Body Mass Index

    BMI was recorded in kg/m\^2.

    period of 6 weeks

  • Sex/Gender

    Sex: Female, Male

    period of 6 weeks

Secondary Outcomes (1)

  • The Mini-Mental State Test for Cognitive status

    period of 6 weeks

Study Arms (2)

Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia

EXPERIMENTAL

The study included a total of 32 volunteers between the ages of 65-80, who stayed in Karaman Ahmet Mete Nursing Home, Elderly Care and Rehabilitation Center, with mild or moderate Alzheimer's dementia diagnosed by a neurologist. As a result of the power analysis, it was calculated that at least 16 individuals could be included in each group (at least 32 individuals in total). Randomization was performed by the sealed-envelope method. According to this method, 4 females and 12 males were determined to be in the control group, while 5 females and 11 males were determined to be in the training group. The evaluation was completed before the intervention. The same evaluation was conducted after 6 weeks. The training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes, and each patient was trained with the same games.

Other: Nintendo Wii Virtual Reality Application

Older People With Alzheimer's Dementia

NO INTERVENTION

In the control group, no application was performed during this period, and routine medical treatments were continued. The training group was evaluated before and after the training, while the control group was re-evaluated at the end of the 6th week after the first evaluation. After the study was completed, the volunteers from the control group were also given training.

Interventions

The training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes.

Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • included volunteers between the ages of 65-80 with mild or moderate AD diagnosis,
  • who did not have any difficulty or problems in communicating,
  • who did not have any neurological diseases that disrupt balance and coordination such as a cerebrovascular event, Parkinson's disease, Multiple Sclerosis, and neurological disorder,
  • who obtained a score of 18 - 24 points in the Mini-Mental State Test (MMST)

You may not qualify if:

  • Patients diagnosed with rapidly progressing dementia (infection, vascular, hematologic diseases),
  • Those who could not be contacted during the follow-up period or who did not participate in the training session, those who experienced cardiac and cerebrovascular events, endocrine disorders, fluid-electrolyte imbalance and infection,
  • Those with malignancy and those who received chemotherapy and radiotherapy that causes malignancy, delirium or depression and malignant sensory loss (those with the Semmes-Weinstein monofilament thickness of 4.56 and above),
  • Those with a lower or upper extremity amputation at any level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Ahmet Mete Nursing Home

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Memory DisordersAlzheimer Disease

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Konya Karaman Ahmet Mete Nursing Home

    Karaman Ahmet Mete Nursing Home. Konya in Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kırıkkale University

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 26, 2021

Study Start

January 15, 2018

Primary Completion

June 6, 2018

Study Completion

January 15, 2019

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations