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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01162226
Date of registration: 24/06/2010
Prospective Registration: Yes
Primary sponsor: University of California, San Francisco
Public title: Computer-Based Balance Training for People With Parkinson's Disease
Scientific title: "PD Wii: Computer-based Gait and Balance Training for Parkinson's Patients".
Date of first enrolment: September 2010
Target sample size: 62
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01162226
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Glenna A Dowling, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Ca San Francisco
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Behavioral: gait and balance training program
Primary Outcome(s)
balance [Time Frame: 3 months]
gait [Time Frame: 3 months]
Secondary Outcome(s)
overall functional status [Time Frame: 3 months]
balance [Time Frame: 3 months]
falls [Time Frame: weeks 1-12]
subjective balance [Time Frame: 3 months]
Secondary ID(s)
2R42NS061502-02
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institute of Neurological Disorders and Stroke (NINDS)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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