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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01162226 |
Date of registration:
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24/06/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Computer-Based Balance Training for People With Parkinson's Disease
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Scientific title:
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"PD Wii: Computer-based Gait and Balance Training for Parkinson's Patients". |
Date of first enrolment:
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September 2010 |
Target sample size:
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62 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01162226 |
Study type:
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Interventional |
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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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Glenna A Dowling, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Ca San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. presence of bradykinesia along with at least one of the following: muscular rigidity,
4-6 Hz rest tremor, and postural instability (Gelb, Oliver, & Gilman, 1999; Hughes,
Ben-Shlomo, Daniel, & Lees, 1992).
2. Hoehn & Yahr disease Stage 1 (unilateral disease) to 3 (mild to moderate bilateral
disease, physically independent) (Fahn and Elton, 1987).
Exclusion Criteria:
1. history of strokes, repeated head injury, encephalitis, oculogyric crises,
neuroleptic treatment, MPTP exposure, more than one affected relative, sustained
remission, strictly unilateral features after 3 years, supranuclear gaze palsy, early
severe autonomic involvement or dementia, Babinski sign, tumor, or a negative
response to L-DOPA (Hughes et al., 1992).
2. other neurologic, orthopedic or cardiac problems, cognitive impairment as evidenced
by 5 or more errors on the Mini Mental State Examination (MMSE) (Folstein, Folstein,
& McHugh, 1975)
3. visual or hearing impairments serious enough to interfere with their ability to
interact with the computer-based training program.
Age minimum:
N/A
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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Behavioral: gait and balance training program
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Primary Outcome(s)
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balance
[Time Frame: 3 months]
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gait
[Time Frame: 3 months]
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Secondary Outcome(s)
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overall functional status
[Time Frame: 3 months]
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balance
[Time Frame: 3 months]
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falls
[Time Frame: weeks 1-12]
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subjective balance
[Time Frame: 3 months]
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Secondary ID(s)
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2R42NS061502-02
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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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