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Effects of Training in a Virtual Environment in Healthy Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741402
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
Coordination for the Improvement of Higher Education Personnel
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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).

Condition or disease Intervention/treatment Phase
Elderly Device: Virtual Reality Training Other: Physical Therapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Training in a Virtual Environment on the Performance of Gait, Postural Control and Executive Functions in Healthy Elderly
Study Start Date : February 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Dynamic Gait Index [ Time Frame: Up to 3 months ]
    The scale assesses the ability to adapt the gait during motor tasks with different demands.

  2. Montreal Cognitive Assessment [ Time Frame: Up to 3 months ]
    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.

  3. Falls Efficacy Scale - International [ Time Frame: Up to 3 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741402


Locations
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Brazil
Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University
São Paulo, Brazil, 05360-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Coordination for the Improvement of Higher Education Personnel
Investigators
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Study Director: Maria Elisa P Piemonte, PhD University of São Paulo
Principal Investigator: Keyte Guedes, MS Student University of São Paulo
Principal Investigator: Alexandra M Lobo, MS Student University of São Paulo
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01741402    
Other Study ID Numbers: USPNEC004
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: November 2012
Keywords provided by University of Sao Paulo General Hospital:
Control posture
Gait
Virtual Reality
Elderly