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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02488265 |
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Date of registration:
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21/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Protocol: Balance Training in Parkinson's Disease
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Scientific title:
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Randomized Controlled Trial Protocol: Balance Training With Rhythmical Cues to Improve and Maintain Balance Control in Parkinson's Disease |
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Date of first enrolment:
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July 1, 2015 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02488265 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Maria Elisa P Piemonte, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of São Paulo |
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Name:
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Tamine TC Capato, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of São Paulo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All of the subjects will be diagnosed by neurologists from the Movement Disorders
Ambulatory Clinic of the University of São Paulo Faculty of Medicine Clinics Hospital,
according to the UK Brain Bank criteria [36] and should be at H&Y classification stage
II or III, with a Mini Mental Status Examination (MMSE) [37] score of above 24.
- All patients should also present fall history.
- They should have the capacity to ambulate independently indoors without aid.
Exclusion Criteria:
- These are the presence of neurological, orthopedic or cardiopulmonary problems, an
unstable medication regime, and an inability to understand or adhere to the protocol
because of, for example, cognitive, auditory or visual problems.
- Patients receiving physical therapy training will also be excluded from the training.
Age minimum:
50 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Other: Screening to prevent falls
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Other: Balance Training
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Primary Outcome(s)
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Mini BESTest (MBESTest)
[Time Frame: 30 weeks]
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Secondary Outcome(s)
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New Freezing of gait questonary (NFoG)
[Time Frame: 30 weeks]
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Timed Up and Go test (TUG)
[Time Frame: 30 weeks]
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Push and Release Test
[Time Frame: 30 weeks]
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Falls Efficacy Scale-International (FES-I)
[Time Frame: 30 weeks]
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Berg Balance Scale (BBS)
[Time Frame: 30 weeks]
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UPDRS
[Time Frame: 30 weeks]
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Secondary ID(s)
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Tamine Capato 02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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