"PD Wii: Computer-based Gait and Balance Training for Parkinson's Patients".
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- gait
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
gait
时间窗: 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
时间窗: 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.
次要结局
- falls(weeks 1-12)
- overall functional status(3 months)
- subjective balance(3 months)
- balance(3 months)
研究者
Glenna Dowling
RN, PhD, FAAN
University of California, San Francisco