CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Use of PedaleoVRdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05162040
NCT05162040N/ACompleted

PedaleoVR: Credibility, Usability and Intrinsic Motivation Study of a Virtual Reality Application for Lower Limb Motor Rehabilitation

Werium Assistive Solutions·observational·Posted Dec 17, 2021·Updated Dec 17, 2021

In Brief

An observational study evaluating Use of PedaleoVR for Ataxia, Motor and Hemiparesis. Completed, enrolled 20 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 17, 2021
Enrollment StartOct 1, 2021
Primary CompletionNov 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 4.5 years ago

Interventions

Use of PedaleoVRdevice

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.