Effects of Training in a Virtual Environment in Healthy Elderly

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Elderly

Intervention / Treatment
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* Device: Virtual Reality Training
* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Control posture, Gait, Virtual Reality, Elderly