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Clinical Trials/NCT01162226
NCT01162226
Completed
Phase 2

"PD Wii: Computer-based Gait and Balance Training for Parkinson's Patients".

University of California, San Francisco1 site in 1 country62 target enrollmentSeptember 2010

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
University of California, San Francisco
Enrollment
62
Locations
1
Primary Endpoint
gait
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

This study will be carried out to determine the effectiveness of in-home computer games played by a person with Parkinson's disease for 50 minutes 3 times a week on measures of standing and walking balance.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
July 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Glenna Dowling

RN, PhD, FAAN

University of California, San Francisco

Eligibility Criteria

Inclusion Criteria

  • 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).
  • Hoehn \& Yahr disease Stage 1 (unilateral disease) to 3 (mild to moderate bilateral disease, physically independent) (Fahn and Elton, 1987).

Exclusion Criteria

  • 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).
  • 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)
  • visual or hearing impairments serious enough to interfere with their ability to interact with the computer-based training program.

Outcomes

Primary Outcomes

gait

Time Frame: 3 months

Gait velocity and stride length will be measured with WriteStep Gait and Mobility pads (Abilitations). For the gait analysis, subjects will walk along a 10 foot walkway (gait velocity) that will record the footprint patterns from which we will evaluate the time it takes to walk the distance of the walkway and the average stride length. Each subject will walk according to standard protocol of 1 trial at his/her self-selected speed to enable an accurate representation of usual gait.

balance

Time Frame: 3 months

Balance will be objectively measured using the modified Clinical Test for Sensory Interaction and Balance (CTSIB) (Shumway-Cook \& Horak, 1986). There are 2 conditions with a stable platform (eyes open and eyes closed) and 2 conditions on a less stable foam surface, (eyes open and eyes closed). Following the standardized protocol, subjects will be tested 3 times in each condition on the stable surface and 3 times in each unstable condition for up to thirty seconds each. The number of seconds standing will be summed across all 12 trials for a range of 0-360 seconds.

Secondary Outcomes

  • falls(weeks 1-12)
  • overall functional status(3 months)
  • subjective balance(3 months)
  • balance(3 months)

Study Sites (1)

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