Ataxia, MotorNCT05162040
PedaleoVR: Credibility, Usability and Intrinsic Motivation Study
An observational study of Ataxia, Motor and Hemiparesis, run by Werium Assistive Solutions at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 39 to 88 years
- Conditions the study is for
- Ataxia, Motor, Hemiparesis
- What is being tested?
- Use of PedaleoVR
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Must had been prescribed pedalling exercise as treatment for lower limb rehabilitation caused by stroke, traumatic brain injury, neuro-motor disorders, and neuro-degenerative diseases.
- Must be able to perform a pedalling session with virtual reality technology.
Who cannot join
- An insufficient cognitive state, in particular, presence of dementia or mild cognitive impairment.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PedaleoVR: Credibility, Usability and Intrinsic Motivation Study of a Virtual Reality Application for Lower Limb Motor Rehabilitation
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
Read the 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.
- Conditions
- Ataxia, Motor, Hemiparesis
- Being tested
- Use of PedaleoVR
- Medical subject headings
- Ataxia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Use of PedaleoVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 month.
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.
Measured: through study completion, an average of 1 month.
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.
Measured: through study completion, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Oct 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ataxia, MotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Werium Assistive Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro Lescer, Cajal Institute of the Spanish National Research Council
- Responsible party
- Sponsor
- Investigators
- Ana Rojo, PhD Student, Study chair, Werium Assistive Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162040
- Sponsor's protocol ID
- UsabilityPedaleoVR
- Status last verified
- Dec 2021
- First submitted
- 12 Nov 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1991946J. 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.
PubMed 11132119Ryan 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.
PubMed 33509098Costa 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.
PubMed 32864213Raya 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.
PubMed 30087258Rojo 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.
PubMed 36812248
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PedaleoVR: Credibility, Usability and Intrinsic Motivation Study of a Virtual Reality Application for Lower Limb Motor Rehabilitation
- ClinicalTrials.gov ID
- NCT05162040
- Acronym / sponsor ID
- UsabilityPedaleoVR
- Conditions
- Ataxia, Motor, Hemiparesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Werium Assistive SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Centro Lescer, Cajal Institute of the Spanish National Research Council
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Device: Use of PedaleoVRTwenty 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. |
Who may qualify
- Ages
- 39 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Must had been prescribed pedalling exercise as treatment for lower limb rehabilitation caused by stroke, traumatic brain injury, neuro-motor disorders, and neuro-degenerative diseases.
- Must be able to perform a pedalling session with virtual reality technology.
Key exclusion criteria (4 listed)
- An insufficient cognitive state, in particular, presence of dementia or mild cognitive impairment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of PedaleoVRAll 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. | Device | Experimental Group |
Primary outcome
Usability of the platform
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.
Credibility and Expectancy of the platform
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.
Intrinsic Motivation of the platform
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Background: PubMed 1991946Podsiadlo 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.
- BackgroundJ. Brooke. SUS - A quick and dirty usability scale. Usability Eval. Ind., 1996; 189 (194), pp. 4-7.
- Background: PubMed 11132119Devilly 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.
- BackgroundRyan RM. Control and information in the intrapersonal sphere: an extensión of cognitive evaluation theory. J Pers Soc Psychol. 1982; 43:450-61
- Background: PubMed 33509098Knippenberg 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.
- Background: PubMed 32864213Costa 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.
- Background: PubMed 30087258Raya 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.
- Derived from this study: PubMed 36812248Rojo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Rojo, PhD Student study chair
Werium Assistive Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ataxia, Motor and Hemiparesis, run by Werium Assistive Solutions at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the platform (time frame: through study completion, an average of 1 month.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05162040, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021; AzTrials last refreshed its copy on 3 Nov 2026.