A Pilot Study of the Effects of Balance Training Using the Wii Balance Board on Balance and Ambulation in Adults With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Berg Balance Scale
研究概览
简要总结
The purpose of this study is to assess the facilitation of balance in Parkinson's disease (PD) patients using the Nintendo Wii fit, with the ultimate goal of developing a program for function and fitness in this patient population. In this study, PD patients will participate in group exercise classes using the Wii Fit and the effects on balance, postural sway, and quality of life assessed.
详细描述
The study is a cohort study using outpatients with Parkinson's Disease in Hoen and Yahr Stage 2.5 - 3. Participants will have pre- and post-exercise testing, as well as participate in an 8-week balance-training program.
Subjects Subjects will be recruited from the outpatient clinics (physician, therapy) at the Rehabilitation Institute of Chicago (RIC) as well as the Northwestern Movement Disorders Clinic, through the Department of Neurology. Approximately 20 subjects will be screened for inclusion from these institutions and 12 subjects will be enrolled in the study. (see Power analysis below).
Recruitment Procedures
Potential subjects will be approached by their treating outpatient physician (Physiatrist or Neurologist) or Physical or Occupational Therapist to see if they would be interested in participating in the study. The principal investigator will also send introductory letters to his outpatients at RIC informing them of the study. Letters will only be sent to the PI's patients (Dr. Marciniak, Dr. Toledo). Potential subjects will be educated regarding study procedures, risks and benefits, and privacy risks. Informed consent will be obtained only during initial screening and signed if the patient is interested in proceeding. Eligibility criteria will be screened for (See below). Subjects who lack decisional capacity will not included in the study.
Study Procedures This study will involve an initial visit (Visit 1) for screening and baseline data collection. The therapy/intervention sessions will be held 3 times per week for 8 weeks, (Visits 2 - 25), and there will be 1 post-intervention visit for data collection (Visit 26). Subjects will be reimbursed 11 dollars for parking expenses that will be mailed to them weekly in the form of a check. All visits will take place at Abbott Hall, 3rd floor exercise room and all visits will take approximately 1 ½ hrs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, 18 years or greater
- •The patient is able to provide informed consent.
- •Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist
- •Hoehn and Yahr Stage 2.5-3
- •Able to ambulate at least 150 ft without an assistive device per patient report
- •On stable doses of Parkinson's medications for at least 2 weeks prior to study onset
- •Endurance sufficient to stand at least 20 minutes unassisted per patient report
排除标准
- •Mini Mental Status Exam (MMSE) < 24
- •Anticipated change in Parkinson's medications in the duration of study
- •Uncontrolled orthostasis
- •Symptomatic coronary artery disease
- •Fracture of lower limb within 6 months prior to study onset
- •Other neurologic diagnosis, including Multiple Sclerosis
- •Other vestibular disease
- •Untreated severe depression (depression of greater than or equal 20 on the Geriatric Depression Scale)
- •Acute illness
- •History of, or current, alcohol abuse
- •Significant visual impairment that would inhibit ability to participate in study, with distance vision >20/40
- •Drug induced or inherited Parkinson's Disease
- •Physical therapy within the month prior to study entry
- •Use of the Wii balance board at home as an exercise program
- •Significant camptocormia
- •Physical Therapy during the study duration
- •Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject.
结局指标
主要结局
Berg Balance Scale
时间窗: 8 weeks
次要结局
- Dynamic Gait Index(8 weeks)
- Parkinson's Disease QOL Questionnaire (PDQ-8)(8 weeks)
- Postural Sway(8 weeks)
