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Effect of Virtual Reality on Balance and Gait Speed With Alzheimer's Dementia

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ClinicalTrials.gov Identifier: NCT03928405
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Meral SERTEL, Kırıkkale University

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Dementia Other: Exercises with Nintendo Wii virtual reality device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Effect of Virtual Reality Application on Balance and Gait Speed in Individuals With Alzheimer's Dementia
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : June 6, 2018


Arm Intervention/treatment
Experimental: Virtual reality group
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.
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.
Other Name: Virtual reality game

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. The Tinetti Gait and Balance Test (TGBT) [ Time Frame: 15 minute ]
    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.

  2. The 5-times Sit to Stand Test [ Time Frame: 1 minute ]
    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

  3. The Gait Speed Measurement Test (GSMT) [ Time Frame: 5 minute ]
    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

  4. Mini Mental State Test [ Time Frame: 15 minute ]
    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.



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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928405


Locations
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Turkey
Kirikkale University
Kirikkale, Fabrikalar Street, Turkey, 71100
Kirikkale Universtiy
Kırıkkale, Fabrikalar Street, Turkey, 71100
Sponsors and Collaborators
Kırıkkale University
Investigators
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Study Chair: Fatma KABAKCI Karaman Ahmet Mete Nursing Home for the Elderly Care

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Responsible Party: Meral SERTEL, Assoc. Prof., Kırıkkale University
ClinicalTrials.gov Identifier: NCT03928405     History of Changes
Other Study ID Numbers: Alzheimer,Virtual Reality
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Meral SERTEL, Kırıkkale University:
Alzheimer's Dementia
Balance
Gait Speed
Virtual Reality

Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors