PedaleoVR: Credibility, Usability and Intrinsic Motivation Study
Condition: Ataxia, Motor; Hemiparesis
MeSH terms: Ataxia; Paresis
Study type: Observational

Summary: 
      The objective of this research is to combine the use of inertial systems with virtual reality
      in pedalling exercises in a pilot study with subjects with ataxia or hemiparesis. In
      particular, it is intended to evaluate the validity of the system as a physical training tool
      for pedalling exercises aimed at providing motivational visual stimuli and biofeedback based
      on pedalling cadence to improve the exercise experience and promote adherence to the
      subject's treatment.

      Primary objectives:

        -  To study the estimation of pedalling cadence performed by the system/platform in
           subjects with hemiparesis or ataxia..

        -  To study the usability, credibility and intrinsic motivation characteristics of the
           platform
    

Detailed description: 
      The objective of this research is to evaluate patient adherence to pedalling-based exercise
      training using visual feedback and virtual reality pedalling cadence analysis. In addition,
      the usability, credibility and adherence promotion characteristics of the virtual reality
      platform will be studied.

      Study phases:

      The procedure will be carried out in the following phases detailed below:

      Phase 1: Sample recruitment and participant information. Participants are recruited according
      to the inclusion and exclusion criteria. The subject is informed about the experimentation in
      which he/she is going to participate, its duration and the technical characteristics to be
      used in the study. characteristics to be used in the study. The data to be collected in the
      form of standardized questionnaires are explained to the subject. Personal data will not be
      collected. If the subject is suitable for participation, he/she will be asked to sign the
      corresponding informed consent form. Finally, 3 appointments with the patient will be
      arranged in accordance with the general schedule of the the general schedule of the
      experiment.

      Phase 2: Familiarization practice with the instrumentation. These will be aimed at acquiring
      basic skills in the use of the synchronized use of the virtual reality environment
      synchronized with the pedalling task.

      Phase 3: Experimentation and data acquisition.

      A.1. Pre-assessment: The participant's motor skills are evaluated based on the application of
      physical assessment metrics by the physician. The metrics are the "Timed Up-and-Go" (TUG)
      test and the "6-minute walking" test. Participants with no visual defects, mild cognitive
      impairment and lower limb motor skills could be selected if they also meet the
      inclusion/exclusion criteria.

      A.2. Validation session of the usability of the Virtual Reality Platform in patients with
      Ataxia or Hemiparesis. (Approx. 40 minutes) The intervention consists of a pedalling exercise
      performed on a bicycle or static pedalling station while synchronizing the physical activity
      with the visual feedback of the virtual reality application. Two pedalling sets of 10 minutes
      each are performed, with 5 minutes of rest between sets.

      A.3. Objective Evaluation: Once the exercise task of the first session is completed, the
      participant is asked to rate its usability rating: System Usability Rating Scale (SUS),
      Credibility and Expectancy Questionnaire (CEQ) and Intrinsic Motivation (Intrinsic
      Motivation). (Intrinsic Motivation Inventory, IMI) of the virtual reality application.

      A.4. Subsequent evaluation: The participant's motor skills were evaluated after the three
      pedalling sessions, based on the pedalling sessions, based on the application of physical
      assessment metrics carried out by the physician.
    

Intervention name(s): Use of PedaleoVR
Intervention type(s): Device
Intervention description(s): All participants must undergo an evaluation of their motor skills through the application of physical assessment metrics performed by the physician. The metrics are the Timed Up-and-Go Test (TUG) and the 6-minute walk test.
Next, they must perform a pedaling exercise on a bicycle or stationary pedaling station synchronizing the physical activity with the visual feedback from the virtual reality application. Two pedalling sets of 10 minutes each are performed, with 5 minutes of rest between sets. Finally, the participant is asked to rate the usability: System Usability Rating Scale (SUS), activity credibility (Credibility and Expectancy Questionnaire, CEQ) and intrinsic motivation (Intrinsic Motivation Inventory, IMI) of the virtual reality application.
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Twenty participants met these criteria (15 males and 5 females, mean aged=61.10, SD=12.62)
        diagnosed with (6) ischemic strokes, (1) hemorrhagic stroke, (1) thalamic stroke, (1)
        internal capsule stroke (3) traumatic brain injury (TBI), (1) Parkinson syndrome, (1) mixed
        axonal neuropathy with sensory demyelination, (1) progressive multifocal
        leukoencephalopathy, (1) secondary obstructive hydrocephalus, (1) angioma avernosus
        hemorrhage, (1) hemiprotuberancial hemorrhage - cavernoma, (1) ataxia and (1) cerebral
        artery aneurysm.