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OpenTrials
Completed

NCT Number: NCT01741402

Effects of Training in a Virtual Environment 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).

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Key information

Conditions

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University

São Paulo, 05360-000, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Virtual reality training

Device

The participants of the study trained 10 balance games during 14 sessions

Physical Therapy

Other

Patients of the control group was trained with balance exercises.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Coordination for the Improvement of Higher Education Personnel

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Dec 4, 2012
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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