Comparison of Training in Virtual Environment With and Without Physiotherapeutic Intervention in Chronic Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of balance training in a virtual environment
      with and without physiotherapeutic intervention on the motor function, balance and gait in
      chronic stroke patients.

      It is a prospective, single blinded, randomized clinical trial performed at Center of
      Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of
      São Paulo University. Forty patients will be randomly assigned in control and experimental
      group.
    

Detailed description: 
      The aim of this study is to compare the effects of a balance training program in a virtual
      environment (using a gaming system with balance board device) with and without verbal/manual
      physiotherapeutic intervention, on the motor function, balance and gait in chronic stroke
      patients.

      It is a prospective, single blinded, randomized clinical trial, performed at Center of
      Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of
      São Paulo University.

      Forty chronic stroke patients will be 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 perform more 30 minutes of balance
      training using eight Wii Fit games which stimulate motor and cognitive functions.

      The main outcome measures will be: the lower limb subscale of the Fugl-Meyer Assessment
      (FMA-LE); Balance Evaluation Systems Test (BESTest) and 6- minute walk test (6MWT).
    

Intervention name(s): No Physiotherapeutic Intervention; Physiotherapeutic Intervention
Intervention type(s): Other; Other
Intervention description(s): Experimental group will perform a balance training program in a virtual environment (using a gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) without verbal/manual physiotherapeutic intervention.
Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided.
Then the patient will be invited to start the game, and in the two attempts of the training no manual or verbal assistance will be provided. Physiotherapist participation during training will be restricted to ensuring patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game at the end of each attempt.; Control group will perform a balance training program in a virtual environment (gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) with verbal and manual physiotherapeutic intervention. Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided. Then the patient will be invited to start the game, and in the first attempt of the training physiotherapist will provide manual and verbal assistance, providing corrections on movement (avoiding compensatory movements). In the second attempt, no manual or verbal assistance will be provided (only ensuring patient safety, providing motivational verbal stimuli), allowing the patient to organize his or her performance.
Other intervention name(s): Experimental Group; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Postural Balance; Motor Function; Gait; Virtual Reality Exposure Therapy; Physiotherapist