Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-30 @ 11:21 AM
Study NCT ID:
NCT05243394
Status:
UNKNOWN
Last Update Posted:
2022-11-07
First Post:
2022-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 groups of 22 participants will each follow a different treatment option.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-02-07', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stride lenght', 'timeFrame': '14 weeks', 'description': '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).'}, {'measure': 'Speed', 'timeFrame': '14 weeks', 'description': '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).'}, {'measure': 'Step cadence', 'timeFrame': '14 weeks', 'description': '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).'}, {'measure': 'Stride Length during Dual Task', 'timeFrame': '14 weeks', 'description': '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).'}, {'measure': 'Speed during Dual Task', 'timeFrame': '14 weeks', 'description': '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).'}, {'measure': 'Step cadence during Dual Task', 'timeFrame': '14 weeks', 'description': '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).'}, {'measure': 'Stride Length Variation Coeficient', 'timeFrame': '14 weeks', 'description': "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"}, {'measure': 'Stride Length Variation Coeficient during Dual Task', 'timeFrame': '14 weeks', 'description': "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"}, {'measure': 'Step Cadence Variation Coeficient', 'timeFrame': '14 weeks', 'description': "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"}, {'measure': 'Step Cadence Variation Coeficient during Dual Task', 'timeFrame': '14 weeks', 'description': "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"}], 'secondaryOutcomes': [{'measure': 'Total Cognitive Performance', 'timeFrame': '14 weeks', 'description': '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.'}, {'measure': "Unified Parkinson's Disease Rating Scale (UPDRS)", 'timeFrame': '14 weeks', 'description': '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.'}, {'measure': 'Hoehn & Yahr', 'timeFrame': '14 weeks', 'description': "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."}, {'measure': "Parkinson's Disease Questionnaire 39", 'timeFrame': '14 weeks', 'description': "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."}, {'measure': 'MiniBest Test', 'timeFrame': '14 weeks', 'description': '14-item test to assess dynamic balance. Lower scores mean a worse balance condition.'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': '14 weeks', 'description': '30-question test to assess cognitive function. Lower scored mean a worse cognitive status.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Gamification', 'tDCS', 'Treadmill gait training', 'Dual Task'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '18058946', 'type': 'BACKGROUND', '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.'}, {'pmid': '18808920', 'type': 'BACKGROUND', '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."}, {'pmid': '26940123', 'type': 'BACKGROUND', '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.'}, {'pmid': '28000926', 'type': 'BACKGROUND', '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."}, {'pmid': '32925106', 'type': 'BACKGROUND', '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."}, {'pmid': '26297812', 'type': 'BACKGROUND', '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."}, {'pmid': '23388087', 'type': 'BACKGROUND', '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.'}, {'pmid': '39012877', 'type': 'DERIVED', 'citation': "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': '38915103', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThe 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Idiopathic Parkinson's Disease\n* Stage II - III in the Hoehn and Yahr Scale during ON state\n* Ability to walk for 10 minutes independently without stop\n\nExclusion Criteria:\n\n* Significant cognitive decline based on mini mental status examination (MMSE \\<23)\n* Severe auditory or visual deficits\n* Other neurological/psychiatric conditions\n* Any kind of cardiovascular complications that contraindicates physical activity\n* Clinical history of any brain surgery or deep brain stimulation device"}, 'identificationModule': {'nctId': 'NCT05243394', 'briefTitle': "Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Universitat de Lleida'}, 'officialTitle': "Evaluating the Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease: Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'PI20/00403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gamified virtual reality environtment + tDCS + treadmill gait training', 'description': '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.', 'interventionNames': ['Other: Gamified virtual reality treadmill gait training with tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'Gamified virtual reality environtment + treadmill gait training', 'description': '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.', 'interventionNames': ['Other: Gamified virtual reality treadmill gait training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treadmill gait training', 'description': '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.', 'interventionNames': ['Other: Treadmill gait training']}], 'interventions': [{'name': 'Gamified virtual reality treadmill gait training with tDCS', 'type': 'OTHER', 'description': 'Progressive treadmill gait training in a gamified virtual reality environment with tDCS', 'armGroupLabels': ['Gamified virtual reality environtment + tDCS + treadmill gait training']}, {'name': 'Gamified virtual reality treadmill gait training', 'type': 'OTHER', 'description': 'Progressive treadmill gait training in a gamified virtual reality environment', 'armGroupLabels': ['Gamified virtual reality environtment + treadmill gait training']}, {'name': 'Treadmill gait training', 'type': 'OTHER', 'description': 'Progressive treadmill gait training', 'armGroupLabels': ['Treadmill gait training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25006', 'city': 'Lleida', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Helena Fernández-Lago', 'role': 'CONTACT', 'email': 'helena.fernandez@udl.cat', 'phone': '973702282'}, {'name': 'Pere Bosch-Barceló', 'role': 'CONTACT', 'email': 'pere.bosch@udl.cat', 'phone': '645091315'}], 'facility': 'Institut de Recerca Biomèdica de Lleida', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}], 'centralContacts': [{'name': 'Helena Fernández-Lago', 'role': 'CONTACT', 'email': 'helena.fernandez@udl.cat', 'phone': '973702282'}, {'name': 'Pere Bosch-Barceló', 'role': 'CONTACT', 'email': 'pere.bosch@udl.cat', 'phone': '645091315'}], 'overallOfficials': [{'name': 'Helena Fernández-Lago', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat de Lleida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat de Lleida', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}, {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Helena Fernández-Lago', 'investigatorAffiliation': 'Universitat de Lleida'}}}}