Effects of Training in a Virtual Environment in Healthy Elderly

NCT ID: NCT01741402

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-02-28

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).

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).

Conditions

Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Training

The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.

Group Type: EXPERIMENTAL

Virtual Reality Training

Intervention Type: DEVICE

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

Physical Therapy

The Control Group was trained by conventional Physical Therapy exercises.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

Patients of the control group was trained with balance exercises.

Interventions

Virtual Reality Training

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

Intervention Type: DEVICE

Physical Therapy

Patients of the control group was trained with balance exercises.

Intervention Type: OTHER

Eligibility 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;

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coordination for the Improvement of Higher Education Personnel

OTHER

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Elisa P Piemonte, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Keyte Guedes, MS Student

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Alexandra M Lobo, MS Student

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

USPNEC004

Identifier Type: -

Identifier Source: org_study_id