Effects of Training in a Virtual Environment in Healthy Elderly

Effects of Training in a Virtual Environment on the Performance of Gait, Postural Control and Executive Functions in Healthy Elderly

The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) balance, (2) gait, (3) functionality and (4) cognition ability in older adults. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Thirty-two older adults are randomly in control and experimental group, 16 each one. The study includes only participants scoring at least 24 in the Mini-Mental State Examination to rule out effects of dementia; without the presence of depression, according to the Geriatric Depression Scale of Yesaváge - version 15 (GDS-15 ≤ 5) and scores on the Berg Balance Scale (EBB ≥ 41).

Study Overview

• Status: Completed
• Conditions: Elderly
• Intervention / Treatment: Device: Virtual Reality Training; Other: Physical Therapy

Detailed Description

The objective of this work is to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on balance, gait, functionality and cognition ability in older adults. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Thirty-two older adults are randomly in control and experimental group, 16 each one. Both groups performed 14 training sessions, twice a week, for seven weeks. Each session is composed of a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups performed more 30 minutes of balance training: the control group performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group performed the balance training with 10 Wii Fit games which stimulated motor and cognitive functions. The main outcome measures are: (1) Mini-BESTest of Dynamic Balance Evaluation; (2) Dynamic Gait Index (DGI); (3) Montreal Cognitive Assessment (MoCA); and (4) Falls Efficacy Scale - International (FES-I).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05360-000
    • Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 60 to 85 years.
• Absence of other neurological disorders or co-morbidities that may affect gait;
• Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
• Absence of depression (score above 5 on the Geriatric Depression Scale of Yesaváge - version 15);
• Score on the Berg Balance Scale above 41;
• Vision and hearing adequate or corrected to normal;
• Ability to walk independently;

Exclusion Criteria:

• Biomechanical alterations (other pathologies) that could compromise the completion of training;
• Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during balance and gait training;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Training; The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.	Device: Virtual Reality Training; The participants of the study trained 10 balance games during 14 sessions
Active Comparator: Physical Therapy; The Control Group was trained by conventional Physical Therapy exercises.	Other: Physical Therapy; Patients of the control group was trained with balance exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test	The Mini-BESTest test is a 14-item test that focuses on dynamic balance, specifically anticipatory transitions, postural responses, sensory orientation and dynamic gait.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Gait Index	The scale assesses the ability to adapt the gait during motor tasks with different demands.	Up to 3 months
Montreal Cognitive Assessment	This scale was developed in order to detect mild degrees of cognitive impairment. The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation.	Up to 3 months
Falls Efficacy Scale - International	The Falls Efficacy Scale-International (FES-I)measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity.	Up to 3 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Coordination for the Improvement of Higher Education Personnel
• Investigators: Study Director: Maria Elisa P Piemonte, PhD, University of Sao Paulo; Principal Investigator: Keyte Guedes, MS Student, University of Sao Paulo; Principal Investigator: Alexandra M Lobo, MS Student, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Elderly; Gait; Virtual Reality; Control posture
• Other Study ID Numbers: USPNEC004