Clinical trial NCT01741402: Effects of Training in a Virtual Environment in Healthy Elderly
Official title: Effects of Training in a Virtual Environment on the Performance of Gait, Postural Control and Executive Functions in Healthy Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: Control posture
Gait
Virtual Reality
Elderly
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Coordination for the Improvement of Higher Education Personnel
First posted: 2012-12-04
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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;

Primary outcomes:
measure: Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test
timeFrame: Up to 3 months
Secondary outcomes:
measure: Dynamic Gait Index
timeFrame: Up to 3 months
measure: Montreal Cognitive Assessment
timeFrame: Up to 3 months
measure: Falls Efficacy Scale - International
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University
Study officials:
affiliation: University of Sao Paulo
name: Maria Elisa P Piemonte, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Keyte Guedes, MS Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Alexandra M Lobo, MS Student
role: PRINCIPAL_INVESTIGATOR
References: