NCT03928405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

April 24, 2019

Last Update Submit

April 25, 2019

Conditions

Keywords

Alzheimer's DementiaBalanceGait SpeedVirtual Reality

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Virtual reality group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

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
Virtual reality group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kirikkale University

Kırıkkale, Fabrikalar Street, 71100, Turkey (Türkiye)

Location

Kirikkale Universtiy

Kırıkkale, Fabrikalar Street, 71100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fatma KABAKCI

    Karaman Ahmet Mete Nursing Home for the Elderly Care

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 26, 2019

Study Start

January 1, 2018

Primary Completion

April 30, 2018

Study Completion

June 6, 2018

Last Updated

April 26, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations