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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03928405
Other study ID # Alzheimer,Virtual Reality
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date June 6, 2018

Study information

Verified date April 2019
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date June 6, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercises with Nintendo Wii virtual reality device
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.

Locations

Country Name City State
Turkey Kirikkale University Kirikkale Fabrikalar Street
Turkey Kirikkale Universtiy Kirikkale Fabrikalar Street

Sponsors (1)

Lead Sponsor Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 15 minute
Primary 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 1 minute
Primary 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 5 minute
Primary 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. 15 minute
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