Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-01 @ 2:31 AM
Study NCT ID:
NCT01076712
Status:
UNKNOWN
Last Update Posted:
2010-03-10
First Post:
2010-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Physiotherapy Interventions for Patients With 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': 'D064186', 'term': 'Prenatal Education'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D010353', 'term': 'Patient Education as Topic'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-09', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Movement Disorder Society-Unified Parkinson's Disease Rating Scale", 'timeFrame': 'Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention'}, {'measure': 'Levodopa equivalent daily dosage (LEDD)', 'timeFrame': 'Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention'}], 'secondaryOutcomes': [{'measure': 'Timed Up and Go Test', 'timeFrame': 'Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention'}, {'measure': 'Activities-Specific Balance Confidence Scale (Chinese version)', 'timeFrame': 'Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention'}, {'measure': "Parkinson's Disease Questionnaire (Standard Chinese Version)", 'timeFrame': 'Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention', 'description': "Parkinson's Disease Questionnaire (Standard Chinese Version) - PDQ-39 (Chinese)"}, {'measure': 'Number of Injurious Falls', 'timeFrame': 'Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '17229744', 'type': 'BACKGROUND', 'citation': "Nieuwboer A, Kwakkel G, Rochester L, Jones D, van Wegen E, Willems AM, Chavret F, Hetherington V, Baker K, Lim I. Cueing training in the home improves gait-related mobility in Parkinson's disease: the RESCUE trial. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):134-40. doi: 10.1136/jnnp.200X.097923."}, {'pmid': '12917847', 'type': 'BACKGROUND', 'citation': "Hirsch MA, Toole T, Maitland CG, Rider RA. The effects of balance training and high-intensity resistance training on persons with idiopathic Parkinson's disease. Arch Phys Med Rehabil. 2003 Aug;84(8):1109-17. doi: 10.1016/s0003-9993(03)00046-7."}, {'pmid': '17826461', 'type': 'BACKGROUND', 'citation': "Herman T, Giladi N, Gruendlinger L, Hausdorff JM. Six weeks of intensive treadmill training improves gait and quality of life in patients with Parkinson's disease: a pilot study. Arch Phys Med Rehabil. 2007 Sep;88(9):1154-8. doi: 10.1016/j.apmr.2007.05.015."}, {'pmid': '19025984', 'type': 'RESULT', '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': '11175678', 'type': 'RESULT', 'citation': 'Morris S, Morris ME, Iansek R. Reliability of measurements obtained with the Timed "Up & Go" test in people with Parkinson disease. Phys Ther. 2001 Feb;81(2):810-8. doi: 10.1093/ptj/81.2.810.'}, {'pmid': '17398252', 'type': 'RESULT', 'citation': 'Mak MK, Lau AL, Law FS, Cheung CC, Wong IS. Validation of the Chinese translated Activities-Specific Balance Confidence scale. Arch Phys Med Rehabil. 2007 Apr;88(4):496-503. doi: 10.1016/j.apmr.2007.01.018.'}, {'pmid': '12360555', 'type': 'RESULT', 'citation': "Tsang KL, Chi I, Ho SL, Lou VW, Lee TM, Chu LW. Translation and validation of the standard Chinese version of PDQ-39: a quality-of-life measure for patients with Parkinson's disease. Mov Disord. 2002 Sep;17(5):1036-40. doi: 10.1002/mds.10249."}, {'pmid': '38588457', 'type': 'DERIVED', 'citation': "Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3."}, {'pmid': '36602886', 'type': 'DERIVED', 'citation': "Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2."}]}, 'descriptionModule': {'briefSummary': "Parkinson's Disease is an incurable and progressive disease. Treatment includes medication and non-pharmacological intervention such as physiotherapy. Physiotherapy is a main component of non-pharmacological interventions. It includes exercise to strengthen the muscles; improves balance and walking, and adopts the use of visual cue training. Treatment has been found to be effective in patients with mild impairment up to 6 months post-treatment. The present study will investigate the effectiveness of treatment for patients with mild to moderate impairment for short term (3-month) and long term (1 year). The hypothesis is that compared to patient education alone, physiotherapy intervention for patients with Parkinson's disease leads to improve function and quality of life.", 'detailedDescription': "Parkinson's disease (PD) is an incurable and progressive disease (Rubenis 2007). Current management include medical, neuro-surgical and non-pharmacological intervention. Physiotherapy is a major component in non-pharmacological interventions. Effective interventions including visual or auditory cues improves gait (Nieuwboer et al. 2007), exercise is effective in improving balance (Hirsch et al 2003); intense treadmill training improves motor control, quality of life and walking speed so as to sustain improvement in gait speed and motor control post 4 weeks of treatment (Herman et al 2007). Patient with PD attending physiotherapy twice weekly, one and half hour for 12 weeks showed improvement in walking speed and Activities of Daily Living (Ellis et al 2005). However, the majority of focus on patients in the Hoehn and Yahr stage of 2 to 3 and long term effect is lacking (Kwakkel et al 2007). A knowledge gap is present in the effectiveness of physiotherapy training of patients with Parkinson's disease in the more advanced stage of disease and long term effect is lacking. The aim of the study is to investigate the immediate, short-term \\& long-term clinical effects of physiotherapy training of patients with Parkinson's disease. The hypothesis is that compared to patient education alone, physiotherapy intervention for patients with Parkinson's disease leads to improve function and quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Stable medication usage\n* Hoehn and Yahr stage II to IV\n* At least 1 score of 2 or more for at least 1 limb of either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS)\n* Able to walk independently\n* No severe cognitive impairments (Mini-Mental State Examination - Chinese Cantonese version) score greater than 24\n\nExclusion Criteria:\n\n* Other severe neurological, cardiopulmonary, or orthopedic disorders\n* Having participated in a physiotherapy or rehabilitation program in previous 2 months"}, 'identificationModule': {'nctId': 'NCT01076712', 'briefTitle': "Effectiveness of Physiotherapy Interventions for Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Queen Elizabeth Hospital, Hong Kong'}, 'officialTitle': "The Effectiveness of Physiotherapy Interventions in Patients With Parkinson's Disease, a Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'KCKESOP0016a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physiotherapy Interventions', 'description': 'Physiotherapy Interventions including strengthening exercise, balance training, gait training with visual cue, gait training with treadmill.', 'interventionNames': ['Other: Physiotherapy Interventions']}, {'type': 'OTHER', 'label': 'Education', 'description': 'Education', 'interventionNames': ['Other: Education Classes']}], 'interventions': [{'name': 'Physiotherapy Interventions', 'type': 'OTHER', 'description': 'Physiotherapy interventions including strengthening exercise, balance training, gait training with visual cus and gait training with treadmill', 'armGroupLabels': ['Physiotherapy Interventions']}, {'name': 'Education Classes', 'type': 'OTHER', 'otherNames': ['Education'], 'description': 'Education Classes', 'armGroupLabels': ['Education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'CW Woo', 'role': 'CONTACT', 'email': 'woocw@ha.org.hk', 'phone': '29586218'}, {'name': 'YF Cheung, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'HF Chan, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'HM Chan, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'MY Lau, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'HS Chan', 'role': 'SUB_INVESTIGATOR'}, {'name': 'HF Mak', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'CW WOO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physiotherapy Department, Queen Elizabeth Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Elizabeth Hospital, Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'WOO Cheuk Wai', 'oldOrganization': 'Physiotherapy Department, Queen Elizabeth Hospital'}}}}