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Clinical Trials/NCT01741402
NCT01741402CompletedNot Applicable

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

University of Sao Paulo General Hospital1 site in 1 country32 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
1
Primary Endpoint
Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test

Study Overview

Brief Summary

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).

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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;

Arms & Interventions

Virtual Reality Training

Experimental

The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.

Intervention: Virtual Reality Training (Device)

Physical Therapy

Active Comparator

The Control Group was trained by conventional Physical Therapy exercises.

Intervention: Physical Therapy (Other)

Outcomes

Primary Outcomes

Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test

Time Frame: Up to 3 months

The Mini-BESTest test is a 14-item test that focuses on dynamic balance, specifically anticipatory transitions, postural responses, sensory orientation and dynamic gait.

Secondary Outcomes

  • Falls Efficacy Scale - International(Up to 3 months)
  • Dynamic Gait Index(Up to 3 months)
  • Montreal Cognitive Assessment(Up to 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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