Overview

This trial is active, not recruiting.

Condition elderly
Treatments virtual reality training, physical therapy
Sponsor University of Sao Paulo General Hospital
Collaborator Coordination for the Improvement of Higher Education Personnel
Start date February 2010
End date January 2013
Trial size 32 participants
Trial identifier NCT01741402, USPNEC004

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.
virtual reality training
The participants of the study trained 10 balance games during 14 sessions
(Active Comparator)
The Control Group was trained by conventional Physical Therapy exercises.
physical therapy
Patients of the control group was trained with balance exercises.

Primary Outcomes

Measure
Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test
time frame: Up to 3 months

Secondary Outcomes

Measure
Dynamic Gait Index
time frame: Up to 3 months
Montreal Cognitive Assessment
time frame: Up to 3 months
Falls Efficacy Scale - International
time frame: Up to 3 months

Eligibility Criteria

Male or female participants from 60 years up to 85 years old.

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;

Additional Information

Official title Effects of Training in a Virtual Environment on the Performance of Gait, Postural Control and Executive Functions in Healthy Elderly
Principal investigator Keyte Guedes, MS Student
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.