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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05162040
Other study ID # UsabilityPedaleoVR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date November 1, 2021

Study information

Verified date December 2021
Source Werium Assistive Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Use of PedaleoVR
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.

Locations

Country Name City State
Spain Werium Assistive Solutions Arganda Del Rey Madrid

Sponsors (3)

Lead Sponsor Collaborator
Werium Assistive Solutions Cajal Institute of the Spanish National Research Council, Centro Lescer

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary Usability of the platform 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. through study completion, an average of 1 month.
Primary Credibility and Expectancy of the platform 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. through study completion, an average of 1 month.
Primary Intrinsic Motivation of the platform 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. through study completion, an average of 1 month.
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