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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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13 April 2015 |
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Main ID: |
NCT02207387 |
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Date of registration:
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28/07/2014 |
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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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Ambulosono Rasagiline Musical Walking Study
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Scientific title:
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A Sensorimotor Contingency-based Musical Walking Program for People Living With Parkinson's Disease |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02207387 |
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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, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Tammy Kang |
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Address:
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Telephone:
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604 822 9722 |
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Email:
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tammy.kang@ubc.ca |
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Affiliation:
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Name:
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Martin J McKeown, MD |
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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 British Columbia |
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Name:
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Silke Cresswell, MD |
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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 British Columbia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Over 19 years of age
- Confirmed diagnosis of Parkinson's Disease
- Can walk 5 to 10 minutes unassisted
- Have a safe place to walk (outdoor or indoor)
- Have mild to moderate Parkinson's disease (HY1-3)
- Be able to lay flat in the scanner for the period of the study
- No reliance on wheelchair or other walking aid for ambulation
- Absence of any other serious medical conditions such as hearing impairment and
dementia
- No history of other neurological and psychiatric illnesses
- No recent musculoskeletal impairment or injuries that may prevent walking
Exclusion Criteria:
- Under 19 years of age
- Unconfirmed PD diagnosis
- Require walking aid, wheelchair-bound
- No access to safe walking pathway
- Severe PD (Hoehn & Yahr stages>3)
- Impaired hearing
- Atypical Parkinsonism
- Concurrent dementia
- Recent knee, hip or foot injury (need permission from doctor)
Exclusion Criteria for fMRI
- Pacemaker
- Brain aneurysm clip
- Cochlear implant
- Recent surgery within the past 6 weeks
- Possibility of pregnancy
- Electrical stimulator for nerves or bones
- Implanted infusion pump
- History of any eye injury involving metal fragments
- History of working with metals (grinding, machining, or welding)
- Artificial heart valve
- Orthopaedic hardware (artificial joint, plate, screws, rods)
- Other metallic prostheses
- Coil, catheter or filter in any blood vessel
- Ear or eye implant
- Recent tattoos within the past 6 weeks
- Shrapnel, bullets, or other metallic fragments
- Medication releasing skin patches (nicotine, birth control, nitroglycerine)
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Azilect
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Behavioral: Exercise
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Other: Music
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Primary Outcome(s)
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Change from baseline in brain imaging signals (fMRI)
[Time Frame: one month and four months]
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Secondary Outcome(s)
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Change from baseline in cognition of PD
[Time Frame: baseline and one month and four months]
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Change from baseline in motor symptoms of PD
[Time Frame: baseline and one month and four months]
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Secondary ID(s)
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H13-02074
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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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