Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease
NCT ID: NCT05243394
Last Updated: 2022-11-07
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
66 participants
INTERVENTIONAL
2023-01-31
2024-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Immersive Virtual Reality to Improve Gait in Parkinson's Disease
NCT03727529
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
NCT04117737
Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease
NCT02516644
Treadmill in the Rehabilitation of Parkinsonian Gait
NCT03815409
Effects of iVR Treadmill on Gait in PD
NCT04019158
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Gamified virtual reality environtment + tDCS + treadmill gait training
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.
Gamified virtual reality treadmill gait training with tDCS
Progressive treadmill gait training in a gamified virtual reality environment with tDCS
Gamified virtual reality environtment + treadmill gait training
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.
Gamified virtual reality treadmill gait training
Progressive treadmill gait training in a gamified virtual reality environment
Treadmill gait training
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.
Treadmill gait training
Progressive treadmill gait training
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gamified virtual reality treadmill gait training with tDCS
Progressive treadmill gait training in a gamified virtual reality environment with tDCS
Gamified virtual reality treadmill gait training
Progressive treadmill gait training in a gamified virtual reality environment
Treadmill gait training
Progressive treadmill gait training
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stage II - III in the Hoehn and Yahr Scale during ON state
* Ability to walk for 10 minutes independently without stop
Exclusion Criteria
* 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
50 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Turku
OTHER
University of Maryland, Baltimore
OTHER
Universitat de Lleida
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Helena Fernández-Lago
Lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Helena Fernández-Lago
Role: PRINCIPAL_INVESTIGATOR
Universitat de Lleida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut de Recerca Biomèdica de Lleida
Lleida, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Shahed 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.
Mehrholz 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.
Dockx 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.
Schootemeijer 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.
Broeder 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.
Mirelman 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.
Bosch-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.
Bosch-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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PI20/00403
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.