CClinicalTrials.gg
CompletedNCT03928405Updated Apr 26, 2019

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

An interventional study of Exercises with Nintendo Wii virtual reality device in Alzheimer's Dementia, sponsored by Kırıkkale University. Completed at 2 sites in Turkey. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-26.

Sponsored by Kırıkkale University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2018, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alzheimer's Dementia

Keywords

  • Alzheimer's Dementia
  • Balance
  • Gait Speed
  • Virtual Reality
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 32 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Kırıkkale University is the lead sponsor of 112 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherExercises 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.

    Also known as: Virtual reality game

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 minute

  2. 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

    Time frame: 1 minute

  3. 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

    Time frame: 5 minute

  4. 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.

    Time frame: 15 minute

07

Study locations

2 sites
  • Kirikkale University
    Kirikkale, Fabrikalar Street 71100, Turkey
  • Kirikkale Universtiy
    Kırıkkale, Fabrikalar Street 71100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03928405
Lead sponsor
Kırıkkale University
Responsible party
Meral SERTEL (Assoc. Prof., Kırıkkale University) — Principal investigator
First posted
Apr 26, 2019
Start date
Jan 1, 2018
Primary completion
Apr 30, 2018
Completion
Jun 6, 2018
Last update
Apr 26, 2019

Study contacts

Fatma KABAKCI
study chair · Karaman Ahmet Mete Nursing Home for the Elderly Care

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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