Clinical trial NCT05243394: Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Virtual Reality
Gamification
tDCS
Treadmill gait training
Dual Task
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
Collaborators: name: University of Turku
name: University of Maryland, Baltimore
First posted: 2022-02-17
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups of 22 participants will each follow a different treatment option.
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stride lenght
timeFrame: 14 weeks
measure: Speed
timeFrame: 14 weeks
measure: Step cadence
timeFrame: 14 weeks
measure: Stride Length during Dual Task
timeFrame: 14 weeks
measure: Speed during Dual Task
timeFrame: 14 weeks
measure: Step cadence during Dual Task
timeFrame: 14 weeks
measure: Stride Length Variation Coeficient
timeFrame: 14 weeks
measure: Stride Length Variation Coeficient during Dual Task
timeFrame: 14 weeks
measure: Step Cadence Variation Coeficient
timeFrame: 14 weeks
measure: Step Cadence Variation Coeficient during Dual Task
timeFrame: 14 weeks
Secondary outcomes:
measure: Total Cognitive Performance
timeFrame: 14 weeks
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 14 weeks
measure: Hoehn & Yahr
timeFrame: 14 weeks
measure: Parkinson's Disease Questionnaire 39
timeFrame: 14 weeks
measure: MiniBest Test
timeFrame: 14 weeks
measure: Montreal Cognitive Assessment
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Institut de Recerca Biomèdica de Lleida
Study officials:
affiliation: Universitat de Lleida
name: Helena Fernández-Lago
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.