NCT01741402

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 12, 2017

Status Verified

November 1, 2012

Enrollment Period

2.9 years

First QC Date

November 30, 2012

Last Update Submit

April 11, 2017

Conditions

Elderly

Keywords

Control postureGaitVirtual RealityElderly

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Dynamic Gait Index

    Up to 3 months

  • Montreal Cognitive Assessment

    Up to 3 months

  • Falls Efficacy Scale - International

    Up to 3 months

Study Arms (2)

Virtual Reality Training

EXPERIMENTAL

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

Device: Virtual Reality Training

Physical Therapy

ACTIVE COMPARATOR

The Control Group was trained by conventional Physical Therapy exercises.

Other: Physical Therapy

Interventions

Virtual Reality TrainingDEVICE

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

Virtual Reality Training
Physical TherapyOTHER

Patients of the control group was trained with balance exercises.

Physical Therapy

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05360-000, Brazil

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Maria Elisa P Piemonte, PhD

    University of Sao Paulo

    STUDY DIRECTOR

  • Keyte Guedes, MS Student

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Alexandra M Lobo, MS Student

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 4, 2012

Study Start

February 1, 2010

Primary Completion

January 1, 2013

Study Completion

February 1, 2014

Last Updated

April 12, 2017

Record last verified: 2012-11

Locations

BR(1)