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

NCT05243394 | Unknown

• 1 other identifier: PI20/00403
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Virtual Reality; Gamification; tDCS; Treadmill gait training; Dual Task

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Total Cognitive Performance

  14 weeks

• Unified Parkinson's Disease Rating Scale (UPDRS)

  14 weeks

• Hoehn & Yahr

  14 weeks

• Parkinson's Disease Questionnaire 39

  14 weeks

• MiniBest Test

  14 weeks

Study Arms (3)

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.

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.

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.

Other: Treadmill gait training

Interventions

Gamified virtual reality treadmill gait training with tDCS OTHER

Progressive treadmill gait training in a gamified virtual reality environment with tDCS

Gamified virtual reality environtment + tDCS + treadmill gait training

Gamified virtual reality treadmill gait training OTHER

Progressive treadmill gait training in a gamified virtual reality environment

Gamified virtual reality environtment + treadmill gait training

Treadmill gait training OTHER

Progressive treadmill gait training

Treadmill gait training

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat de Lleida: lead
• University of Turku: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

Institut de Recerca Biomèdica de Lleida

Lleida, 25006, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 18058946 BACKGROUND

• 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.

  PMID: 18808920 BACKGROUND

• 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.

  PMID: 26940123 BACKGROUND

• 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.

  PMID: 28000926 BACKGROUND

• 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.

  PMID: 32925106 BACKGROUND

• 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.

  PMID: 26297812 BACKGROUND

• 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.

  PMID: 23388087 BACKGROUND

• 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.

  PMID: 39012877 DERIVED

• 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.

  PMID: 38915103 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Helena Fernández-Lago

  Universitat de Lleida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Fernández-Lago

CONTACT

973702282; helena.fernandez@udl.cat

Pere Bosch-Barceló

CONTACT

645091315; pere.bosch@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome measuring assessors will not know from which group any of the participants comes from, and will have no interaction with any of the interventions applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 3 groups of 22 participants will each follow a different treatment option.

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 17, 2022
• Study Start: January 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)