The Effect of Virtual Reality-based Training Program on Improving Upper-Limb Functions in Participants With Stroke.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke is the third commonest cause of death and is probably the commonest cause of severe
      disability. Upper limb recovery after stroke is unacceptably poor with only 50% of stroke
      survivors likely to regain some functional use. In many disabilities, the rehabilitation
      process is of long duration and clinicians face the challenge of identifying a variety of
      meaningful and motivating intervention tasks that may be adapted and graded to facilitate
      this process.. Motor learning models emphasize that self-generated voluntary actions should
      be used and repeated in playful and motivational settings and that the difficulties of the
      task have to be at an appropriate level for successful learning. Motivation to use the
      hemiplegic upper extremity was considered to be the most important factor in guaranteeing
      intense practice and was achieved through the patient's individual inner drive and motivation
      for play. Virtual reality-based therapy is one of the most innovative and developments in
      rehabilitation technology. Enhanced feedback provided by a virtual reality system has been
      shown to promote motor learning in normal subjects. Interaction with objects in a virtual
      environment (VE) through grasping and manipulation is an important feature of future virtual
      reality simulations. Until now, there has been limited research involving the inclusion of
      virtual reality gaming systems in neuro-rehabilitation for hemiplegic patients. So the
      purpose of this study will be evaluation of the efficacy of virtual reality technology on
      improving the function of the involved upper extremity in Saudi patients having stroke.
    

Detailed description: 
      This research project will achieve its objectives and outcomes in five phases:

      There are 5 phases for this research work: (1) preparation phase, (2) Therapeutic
      intervention phase, (3) Evaluation phase, (4) Phase of data and statistical analyses, (5) The
      phase of Result Publication Phase.

      Phase (1): Preparation phase.

      This phase have been undertaken to set up and identify the inclusion and exclusion criteria
      of participant patients, determination of the sample size and randomization procedure for
      this study, purchasing the instruments that will be used in the study.

      1.1 Setting up participant criteria. (This phase has completed) 1.2 Determination of the
      sample size and randomization procedure. Sample size: 40 patients will participated in this
      study. They will divided randomly to equal groups.

      Randomization: (Not yet recruiting) In order to eliminate bias in treatment, randomization
      will be established for the patients who will be included in both experimental group A &
      control group B. It permits the use of probability theory to express the likelihood that any
      difference in outcome between treatment groups merely indicates chance. Evaluation of the
      patients with stroke will be performed by evaluators who will not participated in application
      of intervention and the therapists will be blinded from the randomization and blinding
      process. Simple randomization using a randomization table created by computer software (i.e.
      computerized sequence generation)

      1.3 Purchasing the instruments. (This phase has completed) The following device has been
      already purchased: Armeo Functional upper extremity rehabilitation (MRF; Hocoma,
      Switzerland). (For treatment)

        -  Other evaluation instruments that will be used in this study are available in the
           University Research Labs

      Phase (2): Therapeutic intervention phase. (This phase has not yet started)

      Therapeutic intervention will be carried out three sessions per week for twelve successive
      weeks for both experimental and control groups. The treatment session will continue 2 hours
      with 15 minute rest between the first and the second hours. (More details are explained in
      the intervention section)

      Phase (3): Evaluation phase. (This phase has not yet started)

      The evaluation phase include the examination of the study predetermined parameters at both
      baseline, and 12 weeks after intervention commencement

      Phase (4): Data and Statistical Analysis phase. This phase will start after all participants
      who will recruited for this study will be examined for the purposes of final collection of
      out-come data.

      The statistical analysis will include:

      The differences in demographics (such as age, height and weight) between study/experimental
      and control groups before treatment will be examined using one-way ANOVA.

      Paired t test will be used to identify the mean differences in outcome measures within groups
      to compare the means of primary and secondary outcome measures between pre-treatment and
      post-treatment for each group.

      One-way ANOVA with post-hoc tests will be used to identify the mean differences in primary
      and secondary outcome measures between study/experimental and control groups.

      Phase (5): Result Publication Phase. This phase will start after all participants who will
      recruited for this study will be examined for the purposes of final collection of out-come
      data
    

Intervention name(s): Armeo®Spring ((Task-oriented upper extremity rehabilitation system); Conventional Physical Therapy Program
Intervention type(s): Device; Other
Intervention description(s): Armeo®Spring is a functional upper extremity rehabilitation device to provide specific therapy with augmented feedback. The Armeo Spring instrument facilitates intensive task-oriented upper extremity therapy after stroke, traumatic brain injury or other neurological diseases and injuries. It combines an adjustable arm support, with augmented feedback and a large 3D workspace that allows functional therapy exercises in a virtual reality environment.; This intervention t will include: muscle facilitation exercises, proprioceptive neuromuscular facilitation exercises, strengthening activities, stretching exercises and postural reactions exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemiplegia; Virtual-Reality; Upper Limb Functions; Balance Performance