Back to resultsEffect of Virtual Reality on Balance and Gait Speed With Alzheimer's Dementia
Primary Purpose
Alzheimer's Dementia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercises with Nintendo Wii virtual reality device
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Dementia focused on measuring Alzheimer's Dementia, Balance, Gait Speed, Virtual Reality
Eligibility Criteria
Inclusion Criteria:
- Having mild or moderate severity of AD
- Lack of communication difficulties or problems
- Volunteering to participate in the study
- Cerebrovascular event,
- Having disturbing the balance and coordination of neurological disease such as Parkinson, MS,
- Mini Mental Test Score, 18 to 24 points from being scored
- being 65-80 aged.
Exclusion Criteria:
- Patients diagnosed with dementia (infection, vascular, hematological diseases), patients who could not be contacted during the follow-up period or who did not come to control, cardiac and cerebrovascular event,
- Endocrine disorder, fluid-electrolyte imbalance and infection
- Patients with malignancy and malignancy, chemotherapy and radiotherapy,
- Patients with delirium or depression
- Those with protective sensation loss (those with Semmes-Weinstein Monofilament Thickness 4.56 and above)
- patients with lower or upper extremity amputations at any level
Sites / Locations
- Kirikkale University
- Kirikkale Universtiy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual reality group
Control Group
Arm Description
The subjects were evaluated with the case report form, the balance and fall risks, the Tinetti Gait and Balance Test (TGBT) and the 5-times Sit to Stand Test, while the gait speed was assessed by the Gait Speed Measurement Test (GSMT). The virtual reality group was trained with games selected from different categories such as balance and aerobic exercises with Nintendo Wii virtual reality device for 6 weeks, 1 session 30 min, 2 times a week. In the control group, no treatment was performed during this period and routine medical treatments were continued. In the first session, each Nintendo Wii components were introduced to each individual. The selected games and how they were played were taught to each individual by the physiotherapist and practically taught. The games were played with the help of physiotherapists in the first session so that individuals could transfer the correct weight on the Nintendo Wii balance board and to use the game console's control.
The sociodemographic characteristics of the subjects were evaluated with the case report form, the balance and fall risks, the Tinetti Gait and Balance Test (TGBT) and the 5-times Sit to Stand Test, while the gait speed was assessed by the Gait Speed Measurement Test (GSMT).the control group was reevaluated at the end of the 6th week after the initial evaluation. After the study was completed, training was given to the volunteers from the control group.
Outcomes
Primary Outcome Measures
The Tinetti Gait and Balance Test (TGBT)
TGBT consists of balance and gait subheadings. For balance, there are 13 items, and 9 items for gait. Items are scored as 0 (abnormal), 1 (adaptive) and 2 (normal) for balance, 0 (abnormal), 1 (normal) for gait. The maximum balance score of the patient is 26 and the maximum gait score is 9. Total score (balance + walking) is 35 points.
The 5-times Sit to Stand Test
5 times sit to stand test is a test that evaluates the functional strength of the lower extremity, balance and fall risk. In order to perform this test, a standard size chair with a stopwatch and a flat back is required. We said to the patient that "Please cross your arms to the other shoulder, and when I say start, sit and stand 5 times in the fastest and straightest way you can". I will measure your time with the stopwatch. The rank of the patients was told to them for sit and stand. In the elderly, if the duration of this period is more than 12 seconds indicated the risk of falling, if it is over 15 seconds, this is an indicator of the presence of a risk of repetitive drop
The Gait Speed Measurement Test (GSMT)
For GSMT, individuals were asked to walk at a speed they wanted on a flat surface of 14 m. Signs were placed on the 2nd and 12th meters of the test area to minimize the speed changes between walking start and walking finish, and to make a more objective measurement. The walking time at this 10-meter distance was measured with the stopwatch and the results were recorded in sec and the walking speed was determined
Mini Mental State Test
It was used to determine the cognitive state before the training. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03928405
Brief Title
Effect of Virtual Reality on Balance and Gait Speed With Alzheimer's Dementia
Official Title
The Effect of Virtual Reality Application on Balance and Gait Speed in Individuals With Alzheimer's Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
June 6, 2018 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of study is to investigate the effect of virtual reality application on balance and gait speed in individuals with Alzheimer's Dementia.
Detailed Description
The aim of study is to investigate the effect of virtual reality application on balance and gait speed in individuals with Alzheimer's Dementia. The study consisted of 32 subjects, which were diagnosed as mild or moderate AD by the neurologist. The balance, fall risks and gait speed were assessed. Training group was trained with games selected from different categories such as balance and aerobic exercises with Nintendo Wii virtual reality device for 6 weeks, 1 session 30 min, 2 times a week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Dementia
Keywords
Alzheimer's Dementia, Balance, Gait Speed, Virtual Reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study consisted of 32 subjects, which were diagnosed as mild or moderate AD by the neurologist. The balance, fall risks and gait speed were assessed. Training group was trained with games selected from different categories such as balance and aerobic exercises with Nintendo Wii virtual reality device for 6 weeks, 1 session 30 min, 2 times a week.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality group
Arm Type
Experimental
Arm Description
The subjects were evaluated with the case report form, the balance and fall risks, the Tinetti Gait and Balance Test (TGBT) and the 5-times Sit to Stand Test, while the gait speed was assessed by the Gait Speed Measurement Test (GSMT). The virtual reality group was trained with games selected from different categories such as balance and aerobic exercises with Nintendo Wii virtual reality device for 6 weeks, 1 session 30 min, 2 times a week. In the control group, no treatment was performed during this period and routine medical treatments were continued. In the first session, each Nintendo Wii components were introduced to each individual. The selected games and how they were played were taught to each individual by the physiotherapist and practically taught. The games were played with the help of physiotherapists in the first session so that individuals could transfer the correct weight on the Nintendo Wii balance board and to use the game console's control.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The sociodemographic characteristics of the subjects were evaluated with the case report form, the balance and fall risks, the Tinetti Gait and Balance Test (TGBT) and the 5-times Sit to Stand Test, while the gait speed was assessed by the Gait Speed Measurement Test (GSMT).the control group was reevaluated at the end of the 6th week after the initial evaluation. After the study was completed, training was given to the volunteers from the control group.
Intervention Type
Other
Intervention Name(s)
Exercises with Nintendo Wii virtual reality device
Other Intervention Name(s)
Virtual reality game
Intervention Description
In the first session, each Nintendo Wii components were introduced to each individual. The selected games and how they were played were taught to each individual by the physiotherapist and practically taught. The games were played with the help of physiotherapists in the first session so that individuals could transfer the correct weight on the Nintendo Wii balance board and to use the game console's control. The patient was supported with verbal and physical feedback when the patient played incorrectly during the games in the next sessions. Games that require serious balance and coordination were considered as a difficult activity for the patient and were not used in this study. The difficulty of the games was set to the simplest level for each patient. As the patients were successful the games' difficulty level was upgraded. The difficulty of the games has been increased according to the classification determined by the Nintendo Wii device.
Primary Outcome Measure Information:
Title
The Tinetti Gait and Balance Test (TGBT)
Description
TGBT consists of balance and gait subheadings. For balance, there are 13 items, and 9 items for gait. Items are scored as 0 (abnormal), 1 (adaptive) and 2 (normal) for balance, 0 (abnormal), 1 (normal) for gait. The maximum balance score of the patient is 26 and the maximum gait score is 9. Total score (balance + walking) is 35 points.
Time Frame
15 minute
Title
The 5-times Sit to Stand Test
Description
5 times sit to stand test is a test that evaluates the functional strength of the lower extremity, balance and fall risk. In order to perform this test, a standard size chair with a stopwatch and a flat back is required. We said to the patient that "Please cross your arms to the other shoulder, and when I say start, sit and stand 5 times in the fastest and straightest way you can". I will measure your time with the stopwatch. The rank of the patients was told to them for sit and stand. In the elderly, if the duration of this period is more than 12 seconds indicated the risk of falling, if it is over 15 seconds, this is an indicator of the presence of a risk of repetitive drop
Time Frame
1 minute
Title
The Gait Speed Measurement Test (GSMT)
Description
For GSMT, individuals were asked to walk at a speed they wanted on a flat surface of 14 m. Signs were placed on the 2nd and 12th meters of the test area to minimize the speed changes between walking start and walking finish, and to make a more objective measurement. The walking time at this 10-meter distance was measured with the stopwatch and the results were recorded in sec and the walking speed was determined
Time Frame
5 minute
Title
Mini Mental State Test
Description
It was used to determine the cognitive state before the training. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points.
Time Frame
15 minute
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:
Having mild or moderate severity of AD
Lack of communication difficulties or problems
Volunteering to participate in the study
Cerebrovascular event,
Having disturbing the balance and coordination of neurological disease such as Parkinson, MS,
Mini Mental Test Score, 18 to 24 points from being scored
being 65-80 aged.
Exclusion Criteria:
Patients diagnosed with dementia (infection, vascular, hematological diseases), patients who could not be contacted during the follow-up period or who did not come to control, cardiac and cerebrovascular event,
Endocrine disorder, fluid-electrolyte imbalance and infection
Patients with malignancy and malignancy, chemotherapy and radiotherapy,
Patients with delirium or depression
Those with protective sensation loss (those with Semmes-Weinstein Monofilament Thickness 4.56 and above)
patients with lower or upper extremity amputations at any level
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma KABAKCI
Organizational Affiliation
Karaman Ahmet Mete Nursing Home for the Elderly Care
Official's Role
Study Chair
Facility Information:
Facility Name
Kirikkale University
City
Kirikkale
State/Province
Fabrikalar Street
ZIP/Postal Code
71100
Country
Turkey
Facility Name
Kirikkale Universtiy
City
Kırıkkale
State/Province
Fabrikalar Street
ZIP/Postal Code
71100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Virtual Reality on Balance and Gait Speed With Alzheimer's Dementia
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