Effects of Training in a Virtual Environment in Chronic Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

The objective of this work will be 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) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke patients. 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. Forty patients will be randomly assigned in control and experimental group, 20 each one.

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, motor function, cognition, balance and gait in chronic stroke patients. 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. Forty chronic stroke patients are randomly in control and experimental group, 20 each one. Both groups conduct 14 training sessions, twice a week, for seven weeks. Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups will performed more 30 minutes of balance training: the control group will performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group will performed the balance training with 10 Wii Fit games which stimulate motor and cognitive functions. The main outcome measures will be: (1) the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); (2) Montreal Cognitive Assessment (MoCA) (3); Balance Evaluation Systems Test (BESTest) and (4) 6- minute walk test (6MWT).

Conditions

Interventions

  • Physical therapy Other
    Intervention Desc: Patients of the control group will be trained with balance exercises.
    ARM 1: Kind: Experimental
    Label: Control group: Physical Therapy
    Description: The Control Group will be trained by conventional Physical Therapy exercises.
  • Virtual Reality Training Other
    Intervention Desc: The participants of the study will be trained 10 balance games during 14 sessions
    ARM 1: Kind: Experimental
    Label: Virtual Reality Training
    Description: The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE) up to 3 months No
Primary Montreal Cognitive Assessment Up to 3 months No
Primary Balance Evaluation Systems Test (BESTest) Up to 3 months No
Secondary 6-minute walk test Up to 3 months Yes
Secondary Limits of Stability Up to 3 months No
Secondary Rhythmic Weight Shift Up to 3 months No
Secondary Stroke Specific Quality of Life Scale up to 3 months No

Sponsors