Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT05043727
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2021-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Exer Gaming on Balance and Gait in Parkinson's Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'each participant will be requested to draw either number one or two from box. Group number one will receive exer gaming treatment plan Each Patient received twenty four sessions. Each treatment session will of 50 minutes with two minutes rest between each exercise. Group two will receive conventional treatment plan which will include balance training, gait training, stretching and strengthening exercises.Treatment session will be of 50 minutes with 2 minutes rest period between each exercise.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Unified Parkinson's diseaserating scale (UPDRS)", 'timeFrame': '50 minutes', 'description': 'this test is specifically used in Parkinson patients to check balance'}], 'secondaryOutcomes': [{'measure': 'dynamic gait index.', 'timeFrame': '50 minutes', 'description': 'to check dynamic balance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postural instability,', 'Parkinson Disease,', 'Exer Game'], 'conditions': ['Parkinson Disease', 'Balance']}, 'referencesModule': {'references': [{'pmid': '25539782', 'type': 'BACKGROUND', 'citation': "Liao YY, Yang YR, Cheng SJ, Wu YR, Fuh JL, Wang RY. Virtual Reality-Based Training to Improve Obstacle-Crossing Performance and Dynamic Balance in Patients With Parkinson's Disease. Neurorehabil Neural Repair. 2015 Aug;29(7):658-67. doi: 10.1177/1545968314562111. Epub 2014 Dec 24."}, {'pmid': '19025984', 'type': 'BACKGROUND', 'citation': "Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340."}, {'pmid': '7627914', 'type': 'BACKGROUND', 'citation': 'Lee RG, Tonolli I, Viallet F, Aurenty R, Massion J. Preparatory postural adjustments in parkinsonian patients with postural instability. Can J Neurol Sci. 1995 May;22(2):126-35. doi: 10.1017/s0317167100040208.'}]}, 'descriptionModule': {'briefSummary': "To compare the effects of exer-gaming with conventional physiotherapy on balance and gait in Parkinson's patients", 'detailedDescription': "Parkinsons Disease is a progressive neuro degenerative disorder manifested by a broad spectrum of motor and non-motor features. Approximately 500 000 people suffer from Parkinson's Disease in the United States and there are approximately 50,000 new cases reported annually . Postural instability, impaired gait, and freezing episodes are all common occurrences in Parkinson's. Agility activities, including supine-to-stand, ambulation, turning, and reaching activities, have been used to reduce freezing episodes, particularly in the early stages of disease.\n\nConventional physical therapy(balance training, stretching and strengthening exercises) being used for the balance and gait training in Parkinson. In recent time, there has been development in such treatment plan. Virtual reality based games have been used for such purposes. This study will look at the effects of virtual reality gaming in patients suffering from Parkinson's disease and its outcomes in term of gait and balance training. A randomized clinical trial will be performed. total 16 patients will be included in the study and will be divided into two groups. VR Group will be receiving virtual reality based exercise plan while the CONVENTIONAL group will receive conventional physical therapy . Division will be done through lottery method. Unified parkinson's disease rating scale and dynamic gait index will be used to collect the data. Treatment frequency will be three days per week for three months ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Diagnosed Parkinson's disease patients in stage I, II,III according to Hoeh n-Yahr classification.\n* Patients with balance and gait disorders\n\nExclusion criteria:\n\n* Other neurological conditions (stroke, Alzheimer)\n* Red flag signs (tumors, fractures, infections etc)\n* Uncontrolled hypertension.\n* Patients with visual disturbances\n* Patients with cognitive disorders"}, 'identificationModule': {'nctId': 'NCT05043727', 'briefTitle': "Effects of Exer Gaming on Balance and Gait in Parkinson's Patients", 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': "Effects of Exer Gaming on Balance and Gait in Parkinson's Patients", 'orgStudyIdInfo': {'id': 'REC/Lhr/2024 Shahbaz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exer gaming treatment plan', 'description': 'Exer gaming treatment plan', 'interventionNames': ['Combination Product: Exer gaming']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional treatment plan', 'description': 'conventional treatment plan', 'interventionNames': ['Combination Product: conventional treatment plan']}], 'interventions': [{'name': 'Exer gaming', 'type': 'COMBINATION_PRODUCT', 'description': 'exer gaming treatment plan will include perfect ten balance, wii skiing, wiicycling. Each Patient will receive twenty four sessions. Each treatment session was of 50 minutes with two minutes rest between each exercise.', 'armGroupLabels': ['Exer gaming treatment plan']}, {'name': 'conventional treatment plan', 'type': 'COMBINATION_PRODUCT', 'description': 'it will receive conventional treatment plan which includes balance training, gait training, stretching and strengthening exercises.Each patient will receive twenty four sessions of conventional physical therapy. Treatment session will be of 50 minutes with 2 minutes rest period between each exercise.', 'armGroupLabels': ['conventional treatment plan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'Fedral', 'country': 'Pakistan', 'facility': 'Riphah International University', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'zeest hashmi, MS NMPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}