Clinical trial NCT01162226: Computer-Based Balance Training for People With Parkinson's Disease
Official title: "PD Wii: Computer-based Gait and Balance Training for Parkinson's Patients".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: gait
movement disorders
balance
function
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2010-07-14
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: gait
timeFrame: 3 months
measure: balance
timeFrame: 3 months
Secondary outcomes:
measure: falls
timeFrame: weeks 1-12
measure: overall functional status
timeFrame: 3 months
measure: subjective balance
timeFrame: 3 months
measure: balance
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of Ca San Francisco
name: Glenna A Dowling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fahn, S., Elton, R., & Members, U. C. (1987). Unified Parkinson's disease rating scale. In S. Fahn, C. D. Mardsen, M. Goldstein & D. Calne (Eds.), Recent Developments in Parkinson's Disease (pp. 153-163). New Jersey: Macmillan Healthcare Information. Folstein, M. F., Folstein, S. E., & McHugh, P. R. (1975).
citation: Folstein MF, Folstein SE, McHugh PR.
citation: Gelb DJ, Oliver E, Gilman S. Diagnostic criteria for Parkinson disease. Arch Neurol. 1999 Jan;56(1):33-9. doi: 10.1001/archneur.56.1.33.
citation: Hughes AJ, Ben-Shlomo Y, Daniel SE, Lees AJ. What features improve the accuracy of clinical diagnosis in Parkinson's disease: a clinicopathologic study. Neurology. 1992 Jun;42(6):1142-6. doi: 10.1212/wnl.42.6.1142.
citation: Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
citation: Shumway-Cook A, Horak FB. Assessing the influence of sensory interaction of balance. Suggestion from the field. Phys Ther. 1986 Oct;66(10):1548-50. doi: 10.1093/ptj/66.10.1548. No abstract available.