Frontal Cortex and Gait Freezing in Parkinson's Disease: Rehabilitation Impact
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Freezing of Gait Index
研究概览
简要总结
This project will relate our new quantification of Freezing of Gait (FoG) in Parkinson's disease, using body worn inertial sensors (Aim I), with abnormalities in state-of-the-art, resting state, functional brain connectivity (Aim II), and determine the number of subjects needed for a future, randomized clinical trial to test the efficacy of our novel, Agility Boot Camp (ABC) rehabilitation intervention for FoG (Aim III). The technological approaches to these aims are cutting edge and will allow us to develop sensitive behavioral and brain biomarkers for gait disorders in Parkinson's disease (PD) for use in future clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 50-90 years old.
- •No musculoskeletal or peripheral or central nervous system disorders (other than idiopathic Parkinson disease, iPD) that could significantly affect balance or gait .
- •Capable of following directions.
- •iPD subjects: United Kingdom Brain Bank criteria, i.e., bradykinesia and at least one of the following: rest tremor, muscular rigidity, and postural instability not cause by visual, vestibular, cerebellar or proprioceptive dysfunction. Unilateral onset, response to levodopa.
排除标准
- •Inability to stand or walk for 2 min without an assistive device
- •Recent changes in medication
- •Excessive use of alcohol or recreational drugs,
- •Contraindications to MRI scans (eg, claustrophobia, metal in body)
- •Intervention subjects will be excluded if: 1) participating in a vigorous exercise program more than 2 x/week, 2) A medical condition that contraindicates exercise participation.
- •Idiopathic PD subjects: Same as above and deep brain stimulation electrodes. Significant tremor that would interfere with MRI scan.
- •Control subjects:
- •Will be matched for age and gender to iPD group.
研究组 & 干预措施
Exercise
Subjects will participate in a 90-minute, group (6 per group) exercise session 3 days per week for 6 weeks (18 sessions). The theoretical basis for our novel Agility Boot Camp (ABC) exercise program is based on research that identified the primary neurophysiological and cognitive constraints that limits balance and mobility in PD. The exercises are designed as a circuit with several types of movement-skills specifically focused on improving different postural domains with cognitive challenges such as memorized sequences and dual tasking.
干预措施: Exercise (Behavioral)
Chronic Disease Management Education
Subjects will also receive (cross-over) six weeks of educational classes. The Education program will teach subjects, chronic disease self-management - how to live better with their parkinsonism. Classes will consist of 6 subjects per group meeting for 90 minute sessions, once a week for six weeks. Subject will do an additional 120 minutes of relaxation at home/week.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Change in Freezing of Gait Index
时间窗: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Quantify amount of freezing in the legs ('trembling of knees'), defined as the square of the total power in the 3-8 Hz band, divided by the square of the total power in the 0.5-3 Hz band.
次要结局
- Change in the New Freezing of Gait Questionnaire (NFOGQ) score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
- Change in Activities of Balance Confidence (ABC) Questionnaire score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
- Change in PDQ-39 score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
- Change in instrumented gait and balance measures(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
- Change in locomotor neural network functional connectivity strength(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
- Change in SCOPA-COG score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
- Change in mini-BESTest score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
- Change in UPDRS score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
研究者
Fay B. Horak
Professor of Neurology
Oregon Health and Science University