Effects of Training in a Virtual Environment in Healthy Elderly

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741402
• Other study ID #: USPNEC004
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: April 11, 2017
• Start date: February 2010
• Est. completion date: February 2014

Study information

• Verified date: November 2012
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Elderly

Intervention

Device:
• Virtual Reality Training
The participants of the study trained 10 balance games during 14 sessions

Other:
• Physical Therapy
Patients of the control group was trained with balance exercises.

Locations

Country	Name	City	State
Brazil	Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Coordination for the Improvement of Higher Education Personnel

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dynamic Gait Index	The scale assesses the ability to adapt the gait during motor tasks with different demands.	Up to 3 months
Secondary	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
Secondary	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