Werium Assistive Solutions
Arganda, Madrid, 28500, Spain
NCT Number: NCT05162040
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
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Notify Me39 year–88 year
All sexes
Observational
Arganda, Madrid, 28500, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: through study completion, an average of 1 month.
Outcome of the SUS questionnaire. The score ranges from 0 to 100. A score of 72.5 or higher is considered good and above 85.0 is excellent.
Time frame: through study completion, an average of 1 month.
Outcome of the CEQ questionnaire. The score ranges from 0 to 27. A score of 13.5 is considered neutral, everything above 13.5 is positive while everything under 13.5 is considered negative.
Time frame: through study completion, an average of 1 month.
Outcome of the IMI questionnaire. The score ranges from 0 to 7. A score of 3.5 is considered neutral, everything above 3.5 is positive while everything under 3.5 is considered negative.
Werium Assistive Solutions
Industry
PedaleoVR: Credibility, Usability and Intrinsic Motivation Study of a Virtual Reality Application for Lower Limb Motor Rehabilitation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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