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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: |
NCT03316365 |
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Date of registration:
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16/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease
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Scientific title:
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Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03316365 |
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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 (Care Provider, Outcomes Assessor).
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Phase:
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N/A
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Contacts
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Name:
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Michael Thaut, 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 Toronto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Hoehn & Yahr (HY) stage III or IV
- At least 2 falls in the past 12 months
- Stable antiparkinsonian medication regime
- Ability to ambulate independently for at least 50 m.
Exclusion Criteria:
- Other neurological or orthopedic conditions
- Medically diagnosed hearing loss
- Dementia (Mini Mental Status Exam score < 24).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Continuous Rhythmic Auditory Stimulation
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Intermittent Rhythmic Auditory Stimulation
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Intervention(s)
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Other: Rhythmic Auditory Stimulation (RAS)
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Primary Outcome(s)
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Fall Index
[Time Frame: Change of the number of fall incidents and severity from baseline assessed by the Fall Index 8 weeks, 16 weeks, and 24 weeks.]
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Secondary Outcome(s)
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Berg Balance Scale (BBS)
[Time Frame: Change in balance from baseline assessed by Berg Balance Scale at 8 weeks, 16 weeks, and 24 weeks.]
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Falls Efficacy Scale (FES)
[Time Frame: Change in level of concern about falling from baseline assessed by Fear of the Falling Questionnaire/Short FES-1 at 8 weeks, 16 weeks, and 24 weeks.]
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Gait
[Time Frame: Change in gait from baseline at 8 weeks, 16 weeks, and 24 weeks.]
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Timed Up and Go (TUG)
[Time Frame: Change in balance and function from baseline assessed by Timed Up and Go at 8 weeks, 16 weeks, and 24 weeks.]
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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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