Back to resultsNintendo Wii Virtual Reality Application In Dementia
Primary Purpose
Age-Related Memory Disorders
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nintendo Wii Virtual Reality Application
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Memory Disorders focused on measuring Alzheimer's Dementia, Muscle strength, Fall, Virtual reality
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Karaman Ahmet Mete Nursing Home
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia
Older People With Alzheimer's Dementia
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Age :mean or median age
Age, Categorical:
>=65 years
Body Mass Index
BMI was recorded in kg/m^2.
Sex/Gender
Sex: Female, Male
Secondary Outcome Measures
The Mini-Mental State Test for Cognitive status
According to the MMST, 24-30 points were considered as normal cognitive levels, 18-23 points were considered as mild cognitive disorders, and 0-17 points were considered as severe cognitive disorders
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04819126
Brief Title
Nintendo Wii Virtual Reality Application In Dementia
Official Title
Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
June 6, 2018 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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).
Detailed Description
Purpose: 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.
Method: The study included a total of 32 volunteers between the ages of 65-80, with mild or moderate AD diagnosed. These individuals were divided into 2 groups as a training group and control group. 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. Mini-Mental State Test, Knee Extension Muscle Strength, Timed Up and Go Test, Tinetti Falls Efficacy Scale results of individuals were recorded in the evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Memory Disorders
Keywords
Alzheimer's Dementia, Muscle strength, Fall, Virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia
Arm Type
Experimental
Arm Description
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.
Arm Title
Older People With Alzheimer's Dementia
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nintendo Wii Virtual Reality Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Age :mean or median age
Description
Age, Categorical:
>=65 years
Time Frame
period of 6 weeks
Title
Body Mass Index
Description
BMI was recorded in kg/m^2.
Time Frame
period of 6 weeks
Title
Sex/Gender
Description
Sex: Female, Male
Time Frame
period of 6 weeks
Secondary Outcome Measure Information:
Title
The Mini-Mental State Test for Cognitive status
Description
According to the MMST, 24-30 points were considered as normal cognitive levels, 18-23 points were considered as mild cognitive disorders, and 0-17 points were considered as severe cognitive disorders
Time Frame
period of 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konya Karaman Ahmet Mete Nursing Home
Organizational Affiliation
Karaman Ahmet Mete Nursing Home. Konya in Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karaman Ahmet Mete Nursing Home
City
Konya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nintendo Wii Virtual Reality Application In Dementia
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