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

April 25, 2019 updated by: Meral SERTEL, Kırıkkale University

The Effect of Virtual Reality Application on Balance and Gait Speed in Individuals With Alzheimer's Dementia

The aim of study is to investigate the effect of virtual reality application on balance and gait speed in individuals with Alzheimer's Dementia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fabrikalar Street
      • Kirikkale, Fabrikalar Street, Turkey, 71100
        • Kirikkale University
      • Kırıkkale, Fabrikalar Street, Turkey, 71100
        • Kirikkale Universtiy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
15 minute
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
1 minute
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
5 minute
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.
15 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kırıkkale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Fatma KABAKCI, Karaman Ahmet Mete Nursing Home for the Elderly Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Alzheimer,Virtual Reality

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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