NCT04377191

Brief Summary

Dementia, a part of geriatric syndrome, is characterized by the deterioration of multiple cognitive domains such as memory, language, orientation, learning and personality as a result of damage to the central nervous system and in terms prognosis persistent and often progressive clinical condition. In the epidemiological studies it is stated that the number of the dementia affected people approximately 2 times in every 20 years. In several studies, it has been mentioned that cognitive disorders affect individuals' motor function such as gait and postural responses. These effects lead to a vicious circle by causing immobilization of individuals due to a decrease in cognitive functions in addition to immobilization due to aging. The lack of pharmacological therapies to change the prognosis of dementia, emphasizes physical activity methods due to its neurological contributions. However, due to the fact that conventional exercise programs are seen as boring in terms of elderly individuals and the exercise attendance rates are low, the virtual reality (VR) training have been preferred recently. To the best of the investigator's knowledge, there is no study examining the effect of different virtual reality trainings on the spatio-temporal characteristics of the gait, posture and balance. Therefore, the aim of this study is to evaluate the effect of different virtual reality trainings on these parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

May 2, 2020

Last Update Submit

May 6, 2020

Conditions

Keywords

dementiavirtual realityexergamegait

Outcome Measures

Primary Outcomes (1)

  • gait speed

    Gait speed was assessed by BTS G-Walk inertial sensor. The sensor, connected to the Lumbal 4-5 intervertebral space via a semi-elastic belt, transfers the spatiotemporal characteristics of the gait to the computer via Bluetooth® 3.0 (G-Studio® software). In our study, participants were asked to walk in a corridor of 8 meters.

    change from baseline at 6 weeks

Secondary Outcomes (4)

  • Spatiotemporal Characteristics of Gait

    change from baseline at 6 weeks

  • Berg Balance Scale

    change from baseline at 6 weeks

  • Timed Up and Go Test

    change from baseline at 6 weeks

  • New York Posture Scale

    change from baseline at 6 weeks

Study Arms (3)

VR 1 Group

EXPERIMENTAL

In this group, participants received standard exercise and exergame training with Microsoft Xbox 360 Kinect for 2 days per week for 6 weeks.

Other: exergameOther: exercise

VR 2 Group

EXPERIMENTAL

In this group, participants received standard exercise and exergame training with ALDA balance gear for 2 days per week for 6 weeks.

Other: exergameOther: exercise

Control Group

ACTIVE COMPARATOR

In this group, participants received only standard exercise for 2 days per week for 6 weeks.

Other: exercise

Interventions

Microsoft Xbox 360 Kinect The exercises were advanced from simple to complex. The program started with exercises in a sitting position. In the next stage, the games requiring weight transfer and use of upper limbs in standing position were continued. The program ended with games that require more complex movements such as lunge and mini squats.

Also known as: virtual reality, Microsoft Xbox 360 Kinect
VR 1 Group

Standard Exercise Program The program included warm-up, main exercise and cooling. Warm-up and cooling included neck, trunk, upper-lower extremity range of movement (ROM) exercises and stretching exercises. Main exercise included postural alignment, strengthening for trunk and lower extremity, balance and walking exercises.

Control GroupVR 1 GroupVR 2 Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with dementia
  • Mini-Mental State Examination (MMSE) score between 18-23 points
  • Able to walk independently with/without a walking aid (a single point cane)
  • Able to speak and understand Turkish
  • Understand simple commands
  • At least primary education

You may not qualify if:

  • Severly vision and hearing problems
  • Undergo acute retinal hemorrhage or ophthalmic surgery
  • Acute or chronic neurological problems
  • Musculoskeletal and/or neurological problems affecting movement and balance
  • Vestibular problem and/or use medicine
  • Uncontrolled cardiovascular disease, congestive heart failure, acute myocarditis, pulmonary hypertension, or using a pacemaker
  • Malignancy
  • Orthopedic or neurological surgery in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dementia

Interventions

ExergamingExercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 6, 2020

Study Start

March 25, 2019

Primary Completion

November 9, 2019

Study Completion

December 24, 2019

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations