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临床试验/NCT01741402
NCT01741402已完成不适用

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

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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;

排除标准

  • •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;

研究组 & 干预措施

Virtual Reality Training

Experimental

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

干预措施: Virtual Reality Training (Device)

Physical Therapy

Active Comparator

The Control Group was trained by conventional Physical Therapy exercises.

干预措施: Physical Therapy (Other)

结局指标

主要结局

Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test

时间窗: 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.

次要结局

  • Falls Efficacy Scale - International(Up to 3 months)
  • Dynamic Gait Index(Up to 3 months)
  • Montreal Cognitive Assessment(Up to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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