PedaleoVR: Credibility, Usability and Intrinsic Motivation Study
NCT ID: NCT05162040
Last Updated: 2021-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2021-10-01
2021-11-01
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Experimental Group
Twenty participants joined the experimental group (15 males and 5 females, mean aged=61.10; SD=12.62) and provided written informed consent to be enrolled onto the study. Participants with neurological pathologies were 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Must be able to perform a pedalling session with virtual reality technology.
Exclusion Criteria
* An unbound bone fracture.
* Severe disorders of vision and/or audition (inability to perceive visual and/or auditory information coming from virtual reality)
* Those whose clinical record ruled out any incompatibility with the use of a virtual reality system.
39 Years
88 Years
ALL
No
Sponsors
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Centro Lescer
UNKNOWN
Cajal Institute of the Spanish National Research Council
OTHER
Werium Assistive Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Ana Rojo, PhD Student
Role: STUDY_CHAIR
Werium Assistive Solutions
Locations
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Werium Assistive Solutions
Arganda, Madrid, Spain
Countries
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References
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Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
J. Brooke. SUS - A quick and dirty usability scale. Usability Eval. Ind., 1996; 189 (194), pp. 4-7.
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
Ryan RM. Control and information in the intrapersonal sphere: an extensión of cognitive evaluation theory. J Pers Soc Psychol. 1982; 43:450-61
Knippenberg E, Timmermans A, Palmaers S, Spooren A. Use of a technology-based system to motivate older adults in performing physical activity: a feasibility study. BMC Geriatr. 2021 Jan 28;21(1):81. doi: 10.1186/s12877-021-02021-3.
Costa V, Ramirez O, Otero A, Munoz-Garcia D, Uribarri S, Raya R. Validity and reliability of inertial sensors for elbow and wrist range of motion assessment. PeerJ. 2020 Aug 11;8:e9687. doi: 10.7717/peerj.9687. eCollection 2020.
Raya R, Garcia-Carmona R, Sanchez C, Urendes E, Ramirez O, Martin A, Otero A. An Inexpensive and Easy to Use Cervical Range of Motion Measurement Solution Using Inertial Sensors. Sensors (Basel). 2018 Aug 7;18(8):2582. doi: 10.3390/s18082582.
Rojo A, Castrillo A, Lopez C, Perea L, Alnajjar F, Moreno JC, Raya R. PedaleoVR: Usability study of a virtual reality application for cycling exercise in patients with lower limb disorders and elderly people. PLoS One. 2023 Feb 22;18(2):e0280743. doi: 10.1371/journal.pone.0280743. eCollection 2023.
Other Identifiers
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UsabilityPedaleoVR
Identifier Type: -
Identifier Source: org_study_id