- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04819126
Nintendo Wii Virtual Reality Application In Dementia
Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia
•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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Konya, Turkey
- Karaman Ahmet Mete Nursing Home
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia
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. |
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.
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No Intervention: Older People With Alzheimer's Dementia
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age :mean or median age
Time Frame: period of 6 weeks
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Age, Categorical: >=65 years |
period of 6 weeks
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Body Mass Index
Time Frame: period of 6 weeks
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BMI was recorded in kg/m^2.
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period of 6 weeks
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Sex/Gender
Time Frame: period of 6 weeks
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Sex: Female, Male
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period of 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Mini-Mental State Test for Cognitive status
Time Frame: period of 6 weeks
|
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
|
period of 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Konya Karaman Ahmet Mete Nursing Home, Karaman Ahmet Mete Nursing Home. Konya in Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karamanoğlu Mehmet Bey U
- Kırıkkale University (Other Identifier: No:04/03)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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