Feasibility of the Lee Silverman Voice Treatment®-BIG Intervention in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Adherence Rate
研究概览
简要总结
Evaluate feasibility (acceptability, subject recruitment/retention, willingness to be randomized, and adherence rates) of delivering the Lee Silverman Voice Treatment®-BIG (LSVT®BIG) intervention with individuals with chronic stroke. Evaluate preliminary effect of the LSVT®BIG intervention on motor function and occupational performance with individuals with chronic stroke.
详细描述
Literature suggests the Lee Silverman Voice Treatment®-BIG (LSVT-BIG®) program is an effective intervention for individuals with Parkinson's Disease (Ebersbach et al., 2015); however, no literature or research exists on the use of this program as an intervention for individuals with stroke. Therefore, this project aims to measure the effectiveness of the LSVT®BIG program with one individual with a stroke to determine if LSVT®BIG is a feasible and effective occupational therapy intervention for this population. The LSVT®BIG program is an intensive program with hands-on treatment sessions 4 days per week for 4 weeks. Clients complete home exercises every day that enhance the hands-on treatment and help promote carry-over of skills learned to daily tasks. The investigators have completed two case studies with clients with chronic stroke who demonstrated improved outcomes in upper extremity motor function and occupational performance. The purpose of this study is to test the LSVT®BIG intervention with a larger clinical population and to demonstrate that LSVT®BIG is an effective and feasible treatment option for improvement in occupational performance and upper extremity motor function with individuals with stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age 18 or older
- •Diagnosis of first-ever ischemic stroke at least 6 months prior as confirmed by medical records
- •Has more than a moderate stroke (NIH Stroke Scale > 20)
- •Can read and write English. To ensure participants can understand instructions in clinic and home exercise sessions
排除标准
- •More than moderate motor deficits (Fugl-Meyer UE Assessment < 32/66)
- •More than mild cognitive impairment (Mini-Mental Status Examination < 24)
- •More than mild balance deficits (Berg Balance Scale <45)
- •Minimal or no impairments from their stroke (NIH Stroke Scale < 6)
- •Currently receiving occupational therapy or physical therapy services
- •Has had more than one stroke
结局指标
主要结局
Adherence Rate
时间窗: 1 year
For each study participant, an percentage of clinic visits and home exercises completed will be calculated. Rates will be averaged within groups.
次要结局
- Retention Rate(1 year)
- Change from baseline in Canadian Occupational Performance Measure (COPM)(4 weeks)
- Change from baseline in PROMIS-43(4 weeks)
- Change from baseline in Upper Extremity Range of Motion(4 weeks)
- Change from baseline in Performance Assessment of Self-Care Skills (PASS)(4 weeks)
- Change from baseline in Wolf Motor Function Test (WMFT)(4 weeks)
- Change from baseline in Modified Ashworth Scale (MAS)(4 weeks)
- Change from baseline in Upper Extremity Strength(4 weeks)
- Recruitment Rate(1 year)
研究者
Rachel Proffitt
Assistant Professor
University of Missouri-Columbia