Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243394
• Other study ID #: PI20/00403
• Status: Recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: September 2024

Study information

• Verified date: November 2022
• Source: Universitat de Lleida
• Contact: Helena Fernández-Lago
• Phone: 973702282
• Email: helena.fernandez[@]udl.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• 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

Locations

Country	Name	City	State
Spain	Institut de Recerca Biomèdica de Lleida	Lleida

Sponsors (3)

Lead Sponsor	Collaborator
Universitat de Lleida	University of Maryland, Baltimore, University of Turku

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. Review. — View 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:CD010760. doi: 10.1002/14651858.CD010760.pub2. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	14 weeks
Primary	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).	14 weeks
Primary	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).	14 weeks
Primary	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).	14 weeks
Primary	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).	14 weeks
Primary	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).	14 weeks
Primary	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	14 weeks
Primary	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	14 weeks
Primary	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	14 weeks
Primary	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	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks
Secondary	MiniBest Test	14-item test to assess dynamic balance. Lower scores mean a worse balance condition.	14 weeks
Secondary	Montreal Cognitive Assessment	30-question test to assess cognitive function. Lower scored mean a worse cognitive status.	14 weeks