Parkinson DiseaseNCT05243394
Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease
A study testing Gamified virtual reality treadmill gait training with tDCS, Gamified virtual reality treadmill gait training and Treadmill gait training in people with Parkinson Disease, run by Universitat de Lleida at 1 site in Spain.
Trial summary
The study aims to compare the effects of treadmill gait training in a gamified virtual reality environment with tDCS versus treadmill gait training in a gamified virtual reality environment versus treadmill training in people with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Gamified virtual reality treadmill gait training with tDCS, Gamified virtual reality treadmill gait training and Treadmill gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2023to Sep 2024
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's Disease
- Stage II - III in the Hoehn and Yahr Scale during ON state
- Ability to walk for 10 minutes independently without stop
Who cannot join
- Significant cognitive decline based on mini mental status examination (MMSE <23)
- Severe auditory or visual deficits
- Other neurological/psychiatric conditions
- Any kind of cardiovascular complications that contraindicates physical activity
- Clinical history of any brain surgery or deep brain stimulation device
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Institut de Recerca Biomèdica de Lleida
Lleida, 25006
Helena Fernández-Lago, 973702282, helena.fernandez@udl.cat
Pere Bosch-Barceló, 645091315, pere.bosch@udl.cat
About this study
Official title: Evaluating the Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease: Randomized Controlled Trial
The study aims to compare the effects of treadmill gait training in a gamified virtual reality environment with tDCS versus treadmill gait training in a gamified virtual reality environment versus treadmill training in people with Parkinson's Disease.
Read the detailed description
Treadmill gait training has been stablished as a solid gait rehabilitation option for people with Parkinson's Disease. However, gait training by itself fails to address the cognitive aspect needed for safe walking, which could be affected by situations in which concurrent tasks must be managed simultaneously to gait. It also lacks motivational aspects key to keep people with Parkinson's Disease adhered to treatment. Virtual reality and gamification are posed as useful tools to address both these issues, turning training into a more engaging activity and allowing complicated gait situations to be trained in a safe environment. Transcranial direct current stimulation (tDCS) could be combined with these mentioned treatment options, which could reinforce the learning of motor and cognitive skills during training.
The aim of this study is to evaluate the effects of the inclusion of a gamified virtual reality environment to a treadmill gait training program with tDCS in PD compared to the same training protocol with virtual reality and without it
- Conditions
- Parkinson Disease
- Being tested
- Gamified virtual reality treadmill gait training with tDCS, Gamified virtual reality treadmill gait training, Treadmill gait training
- Keywords
- Virtual Reality, Gamification, tDCS, Treadmill gait training, Dual Task
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified virtual reality treadmill gait training with tDCSOther
Progressive treadmill gait training in a gamified virtual reality environment with tDCS
Gamified virtual reality treadmill gait trainingOther
Progressive treadmill gait training in a gamified virtual reality environment
Treadmill gait trainingOther
Progressive treadmill gait training
| Study group | Role | What they receive |
|---|---|---|
| Gamified virtual reality environtment + tDCS + treadmill gait training | Experimental | The first group will follow an 18-session gait training protocol for 6 weeks. Duration of the sessions will progressively increase from 20 to 45 minutes from first session to last. They will be immersed in a gamified virtual reality environment in which they will interact with the in-game ambient by having their feet represented on the screen and move as their own on the treadmill. They will also receive tDCS for the first 20 minutes of each session. Receives: Other: Gamified virtual reality treadmill gait training with tDCS |
| Gamified virtual reality environtment + treadmill gait training | Experimental | The second group will follow an 18-session gait training protocol for 6 weeks. Duration of the sessions will progressively increase from 20 to 45 minutes from first session to last. They will be immersed in a gamified virtual reality environment in which they will interact with the in-game ambient by having their feet represented on the screen and move as their own on the treadmill. Receives: Other: Gamified virtual reality treadmill gait training |
| Treadmill gait training | Active comparator | The third group will follow an 18-session gait training protocol for 6 weeks. Duration of the sessions will progressively increase from 20 to 45 minutes from first session to last. Receives: Other: Treadmill gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride lenght
Stride length will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in meters (m).
Measured: 14 weeks
Speed
Speed will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in meters per second (m/s).
Measured: 14 weeks
Step cadence
Step cadence will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in Hertz (Hz).
Measured: 14 weeks
Stride Length during Dual Task
Stride length will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in meters (m).
Measured: 14 weeks
Speed during Dual Task
Speed will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in meters per second (m/s).
Measured: 14 weeks
Step cadence during Dual Task
Step cadence will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in Hertz (Hz).
Measured: 14 weeks
Stride Length Variation Coeficient
Based on standard deviation and mean values of Stride Length data, a new variable will be calculated to assess the variability of stride length in participants' gait. Formula will be the following: (Standard deviation/mean Stride Length)100
Measured: 14 weeks
Stride Length Variation Coeficient during Dual Task
Based on standard deviation and mean values of Stride Length data, a new variable will be calculated to assess the variability of stride length in participants' gait. Formula will be the following (data from Dual Task variable): (Standard deviation/mean Stride Length)100
Measured: 14 weeks
Step Cadence Variation Coeficient
Based on standard deviation and mean values of step cadence data during Dual Task, a new variable will be calculated to assess the variability of step cadence in participants' gait. Formula will be the following: (Standard deviation/mean Step Cadence)100
Measured: 14 weeks
Step Cadence Variation Coeficient during Dual Task
Based on standard deviation and mean values of step cadence data during Dual Task, a new variable will be calculated to assess the variability of step cadence in participants' gait. Formula will be the following (data from Dual Task variable): (Standard deviation/mean Step Cadence)100
Measured: 14 weeks
Secondary outcomes (6)
Total Cognitive Performance
A battery of executive function tests will be applied, which in combination will allow for a total cognitive performance calculation. The used tests to calculate the Total Cognitive Performance are: Trail Making Test, Digit Span Backwards, Word Fluency Phonemic and Semantic, Wisconsin Card Sorting Test, Corsi Block Test, and Tower of London Test. These test scores will be converted to z-test scores and integrated with a formula to obtain the Total Cognitive Performance score.
Measured: 14 weeks
Unified Parkinson's Disease Rating Scale (UPDRS)
The UPDRS is made up of 42 items grouped into four subscales: Section I-mentation, behavior and mood; Section II-activities of daily living (scored for "on" and "off"); Section III-motor exam; and Section IV-complications. Items from Sections I to III are scored on a 4-point scale. Section IV contains dichotomous items and items scored on a 4-point scale for duration or severity. Higher scores indicate more severe impairment.
Measured: 14 weeks
Hoehn & Yahr
Assess symptom progression in Parkinson's Disease based on a 5-stage scale, in which stage 1 is the most autonomous and stage 5 implies bedridden or wheelchair-bound patients unless assisted.
Measured: 14 weeks
Parkinson's Disease Questionnaire 39
Patient-reported 39 item questionnaire to assess Parkinson's Disease related quality of life and health status across 8 dimensions of daily living. Higher scores indicate worse quality of life.
Measured: 14 weeks
MiniBest Test
14-item test to assess dynamic balance. Lower scores mean a worse balance condition.
Measured: 14 weeks
Montreal Cognitive Assessment
30-question test to assess cognitive function. Lower scored mean a worse cognitive status.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study startJan 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups of 22 participants will each follow a different treatment option.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, University of Maryland, Baltimore
- Responsible party
- Principal investigator, Helena Fernández-Lago, Universitat de Lleida
- Investigators
- Helena Fernández-Lago, Principal investigator, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243394
- Sponsor's protocol ID
- PI20/00403
- Status last verified
- Nov 2022
- First submitted
- 20 Jan 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720.
PubMed 18058946Shahed J, Jankovic J. Motor symptoms in Parkinson's disease. Handb Clin Neurol. 2007;83:329-42. doi: 10.1016/S0072-9752(07)83013-2. No abstract available.
PubMed 18808920Mehrholz J, Kugler J, Storch A, Pohl M, Hirsch K, Elsner B. Treadmill training for patients with Parkinson Disease. An abridged version of a Cochrane Review. Eur J Phys Rehabil Med. 2016 Oct;52(5):704-713. Epub 2016 Mar 4.
PubMed 26940123Dockx K, Bekkers EM, Van den Bergh V, Ginis P, Rochester L, Hausdorff JM, Mirelman A, Nieuwboer A. Virtual reality for rehabilitation in Parkinson's disease. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD010760. doi: 10.1002/14651858.CD010760.pub2.
PubMed 28000926Schootemeijer S, van der Kolk NM, Ellis T, Mirelman A, Nieuwboer A, Nieuwhof F, Schwarzschild MA, de Vries NM, Bloem BR. Barriers and Motivators to Engage in Exercise for Persons with Parkinson's Disease. J Parkinsons Dis. 2020;10(4):1293-1299. doi: 10.3233/JPD-202247.
PubMed 32925106Broeder S, Nackaerts E, Heremans E, Vervoort G, Meesen R, Verheyden G, Nieuwboer A. Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. Neurosci Biobehav Rev. 2015 Oct;57:105-17. doi: 10.1016/j.neubiorev.2015.08.010. Epub 2015 Aug 20.
PubMed 26297812Mirelman A, Rochester L, Reelick M, Nieuwhof F, Pelosin E, Abbruzzese G, Dockx K, Nieuwboer A, Hausdorff JM. V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial. BMC Neurol. 2013 Feb 6;13:15. doi: 10.1186/1471-2377-13-15.
PubMed 23388087Bosch-Barcelo P, Climent-Sanz C, Martinez-Navarro O, Masbernat-Almenara M, Pakarinen A, Ghosh PK, Fernandez-Lago H. A treadmill training program in a gamified virtual reality environment combined with transcranial direct current stimulation in Parkinson's Disease: Study protocol for a randomized controlled trial. PLoS One. 2024 Jul 16;19(7):e0307304. doi: 10.1371/journal.pone.0307304. eCollection 2024.
PubMed 39012877Bosch-Barcelo P, Masbernat-Almenara M, Martinez-Navarro O, Tersa-Miralles C, Pakarinen A, Fernandez-Lago H. A gamified virtual environment intervention for gait rehabilitation in Parkinson's Disease: co-creation and feasibility study. J Neuroeng Rehabil. 2024 Jun 24;21(1):107. doi: 10.1186/s12984-024-01399-6.
PubMed 38915103
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05243394
- Acronym / sponsor ID
- PI20/00403
- Conditions
- Parkinson Disease
- Keywords
- Virtual Reality, Gamification, tDCS, Treadmill gait training, Dual Task
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Collaborators
- University of Turku, University of Maryland, Baltimore
- Study start
- Jan 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 17 Feb 2022 (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 study aims to compare the effects of treadmill gait training in a gamified virtual reality environment with tDCS versus treadmill gait training in a gamified virtual reality environment versus treadmill training in people with Parkinson's Disease.
Detailed description
Treadmill gait training has been stablished as a solid gait rehabilitation option for people with Parkinson's Disease. However, gait training by itself fails to address the cognitive aspect needed for safe walking, which could be affected by situations in which concurrent tasks must be managed simultaneously to gait. It also lacks motivational aspects key to keep people with Parkinson's Disease adhered to treatment. Virtual reality and gamification are posed as useful tools to address both these issues, turning training into a more engaging activity and allowing complicated gait situations to be trained in a safe environment. Transcranial direct current stimulation (tDCS) could be combined with these mentioned treatment options, which could reinforce the learning of motor and cognitive skills during training.
The aim of this study is to evaluate the effects of the inclusion of a gamified virtual reality environment to a treadmill gait training program with tDCS in PD compared to the same training protocol with virtual reality and without it
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 groups of 22 participants will each follow a different treatment option.
| Arm | Type | Receives |
|---|---|---|
| Gamified virtual reality environtment + tDCS + treadmill gait training | Experimental | Other: Gamified virtual reality treadmill gait training with tDCSThe first group will follow an 18-session gait training protocol for 6 weeks. Duration of the sessions will progressively increase from 20 to 45 minutes from first session to last. They will be immersed in a gamified virtual reality environment in which they will interact with the in-game ambient by having their feet represented on the screen and move as their own on the treadmill. They will also receive tDCS for the first 20 minutes of each session. |
| Gamified virtual reality environtment + treadmill gait training | Experimental | Other: Gamified virtual reality treadmill gait trainingThe second group will follow an 18-session gait training protocol for 6 weeks. Duration of the sessions will progressively increase from 20 to 45 minutes from first session to last. They will be immersed in a gamified virtual reality environment in which they will interact with the in-game ambient by having their feet represented on the screen and move as their own on the treadmill. |
| Treadmill gait training | Active comparator | Other: Treadmill gait trainingThe third group will follow an 18-session gait training protocol for 6 weeks. Duration of the sessions will progressively increase from 20 to 45 minutes from first session to last. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Parkinson's Disease
- Stage II - III in the Hoehn and Yahr Scale during ON state
- Ability to walk for 10 minutes independently without stop
Key exclusion criteria (5 listed)
- Significant cognitive decline based on mini mental status examination (MMSE <23)
- Severe auditory or visual deficits
- Other neurological/psychiatric conditions
- Any kind of cardiovascular complications that contraindicates physical activity
- Clinical history of any brain surgery or deep brain stimulation device
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 |
|---|---|---|
| Gamified virtual reality treadmill gait training with tDCSProgressive treadmill gait training in a gamified virtual reality environment with tDCS | Other | Gamified virtual reality environtment + tDCS + treadmill gait training |
| Gamified virtual reality treadmill gait trainingProgressive treadmill gait training in a gamified virtual reality environment | Other | Gamified virtual reality environtment + treadmill gait training |
| Treadmill gait trainingProgressive treadmill gait training | Other | Treadmill gait training |
Primary outcome
Stride lenght
Time frame: 14 weeks
Stride length will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in meters (m).
Speed
Time frame: 14 weeks
Speed will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in meters per second (m/s).
Step cadence
Time frame: 14 weeks
Step cadence will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in Hertz (Hz).
Stride Length during Dual Task
Time frame: 14 weeks
Stride length will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in meters (m).
Speed during Dual Task
Time frame: 14 weeks
Speed will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in meters per second (m/s).
Step cadence during Dual Task
Time frame: 14 weeks
Step cadence will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in Hertz (Hz).
Stride Length Variation Coeficient
Time frame: 14 weeks
Based on standard deviation and mean values of Stride Length data, a new variable will be calculated to assess the variability of stride length in participants' gait. Formula will be the following: (Standard deviation/mean Stride Length)100
Stride Length Variation Coeficient during Dual Task
Time frame: 14 weeks
Based on standard deviation and mean values of Stride Length data, a new variable will be calculated to assess the variability of stride length in participants' gait. Formula will be the following (data from Dual Task variable): (Standard deviation/mean Stride Length)100
Step Cadence Variation Coeficient
Time frame: 14 weeks
Based on standard deviation and mean values of step cadence data during Dual Task, a new variable will be calculated to assess the variability of step cadence in participants' gait. Formula will be the following: (Standard deviation/mean Step Cadence)100
Step Cadence Variation Coeficient during Dual Task
Time frame: 14 weeks
Based on standard deviation and mean values of step cadence data during Dual Task, a new variable will be calculated to assess the variability of step cadence in participants' gait. Formula will be the following (data from Dual Task variable): (Standard deviation/mean Step Cadence)100
6 secondary outcomes
Total Cognitive Performance
Time frame: 14 weeks
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 14 weeks
Hoehn & Yahr
Time frame: 14 weeks
Parkinson's Disease Questionnaire 39
Time frame: 14 weeks
MiniBest Test
Time frame: 14 weeks
Montreal Cognitive Assessment
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Background: PubMed 18058946Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720.
- Background: PubMed 18808920Shahed J, Jankovic J. Motor symptoms in Parkinson's disease. Handb Clin Neurol. 2007;83:329-42. doi: 10.1016/S0072-9752(07)83013-2. No abstract available.
- Background: PubMed 26940123Mehrholz J, Kugler J, Storch A, Pohl M, Hirsch K, Elsner B. Treadmill training for patients with Parkinson Disease. An abridged version of a Cochrane Review. Eur J Phys Rehabil Med. 2016 Oct;52(5):704-713. Epub 2016 Mar 4.
- Background: PubMed 28000926Dockx K, Bekkers EM, Van den Bergh V, Ginis P, Rochester L, Hausdorff JM, Mirelman A, Nieuwboer A. Virtual reality for rehabilitation in Parkinson's disease. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD010760. doi: 10.1002/14651858.CD010760.pub2.
- Background: PubMed 32925106Schootemeijer S, van der Kolk NM, Ellis T, Mirelman A, Nieuwboer A, Nieuwhof F, Schwarzschild MA, de Vries NM, Bloem BR. Barriers and Motivators to Engage in Exercise for Persons with Parkinson's Disease. J Parkinsons Dis. 2020;10(4):1293-1299. doi: 10.3233/JPD-202247.
- Background: PubMed 26297812Broeder S, Nackaerts E, Heremans E, Vervoort G, Meesen R, Verheyden G, Nieuwboer A. Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. Neurosci Biobehav Rev. 2015 Oct;57:105-17. doi: 10.1016/j.neubiorev.2015.08.010. Epub 2015 Aug 20.
- Background: PubMed 23388087Mirelman A, Rochester L, Reelick M, Nieuwhof F, Pelosin E, Abbruzzese G, Dockx K, Nieuwboer A, Hausdorff JM. V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial. BMC Neurol. 2013 Feb 6;13:15. doi: 10.1186/1471-2377-13-15.
- Derived from this study: PubMed 39012877Bosch-Barcelo P, Climent-Sanz C, Martinez-Navarro O, Masbernat-Almenara M, Pakarinen A, Ghosh PK, Fernandez-Lago H. A treadmill training program in a gamified virtual reality environment combined with transcranial direct current stimulation in Parkinson's Disease: Study protocol for a randomized controlled trial. PLoS One. 2024 Jul 16;19(7):e0307304. doi: 10.1371/journal.pone.0307304. eCollection 2024.
- Derived from this study: PubMed 38915103Bosch-Barcelo P, Masbernat-Almenara M, Martinez-Navarro O, Tersa-Miralles C, Pakarinen A, Fernandez-Lago H. A gamified virtual environment intervention for gait rehabilitation in Parkinson's Disease: co-creation and feasibility study. J Neuroeng Rehabil. 2024 Jun 24;21(1):107. doi: 10.1186/s12984-024-01399-6.
- 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.
Helena Fernández-Lago principal investigator
Universitat de Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified virtual reality treadmill gait training with tDCS, Gamified virtual reality treadmill gait training and Treadmill gait training in people with Parkinson Disease, run by Universitat de Lleida 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helena Fernández-Lago (973702282, helena.fernandez@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride lenght (time frame: 14 weeks). The study lists 10 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 NCT05243394, which also lists 9 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 7 Nov 2022.