Optimizing the Dose of Rehabilitation After Stroke.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bilateral Arm Reaching Test (BART)
研究概览
简要总结
This study is about rehabilitation of arm function after a stroke. The investigators are testing the dosage of therapy that is needed for meaningful recovery of arm and hand function. Dosage of therapy refers to the amount of time (in this case, the total number of hours) that a person participates in treatment. The investigators hope to learn how much therapy time is needed in order for change to occur in arm and hand function after a person has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or hand at least 6 months ago.
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
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke that occured at least 6 months ago.
- •At least 21 years of age
- •Persistent arm and hand weakness, with some ability to release a grasp
- •Able to provide consent to participate
- •No history of a medical condition that limited arm or hand use prior to the stroke
- •Medically stable
- •Able to participate for 10 months and attend evaluations at the University of Southern California (USC) Health Sciences Campus.
- •Able to communicate in English or Spanish.
排除标准
- •Severe upper extremity sensory impairment
- •Current major depressive disorder
- •Severe arthritis or orthopedic problems that limit arm or hand movement
- •Pain that interferes with daily activities
- •Currently enrolled in other rehabilitation or drug intervention studies
- •Living too far from the training site to participate reliably
- •Receiving oral or injected anti-spasticity medications during study treatment.
- •Pregnancy.
研究组 & 干预措施
High Therapy Dose
Sixty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
干预措施: Accelerated Skill Acquisition Program (ASAP) (Behavioral)
Moderate Therapy Dose
Thirty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
干预措施: Accelerated Skill Acquisition Program (ASAP) (Behavioral)
Low Therapy Dose
Fifteen total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
干预措施: Accelerated Skill Acquisition Program (ASAP) (Behavioral)
Active Monitoring
This is an observation only group.
干预措施: Active Monitoring (Behavioral)
结局指标
主要结局
Bilateral Arm Reaching Test (BART)
时间窗: Change from Baseline to up to 10 months post-randomization
BART is a laboratory-based timed-reaching task for people with stroke that was developed to evaluate upper extremity use in free-choice and forced-use scenarios. BART will be performed 2 times at Baseline, pre- and post- intervention and 1 time a month for 6 months during follow-up to assess changes in upper extremity use relative to dosage of therapy.
Wolf Motor Function Test (WMFT)
时间窗: Change from Baseline to up to 10 months post-randomization
Tests arm function based on time to complete 15 tasks performed with each arm. WMFT will be used to assess change in arm function relative to dose of physical therapy.
Motor Activity Log (MAL)
时间窗: Change from Baseline to up to 10 months post-randomization
Semi-structured interview in which participants are asked to rate the quality of movement (QOM) of their more affected arm for 28 activities of daily living. MAL is used to assess changes in participant perspective of arm use in daily life relative to dose of physical therapy.
Bilateral Arm Reaching Test (BART)
时间窗: Change from Baseline to up to 4 months post-randomization
BART is a laboratory-based timed-reaching task for people with stroke that was developed to evaluate upper extremity use in free-choice and forced-use scenarios. BART will be performed two times per month for the four months following randomization, and one time a month for 6 months during the follow-up period to assess changes in upper extremity use relative to dosage of therapy.
Wolf Motor Function Test (WMFT)
时间窗: Change from Baseline to up to 4 months post-randomization
Tests arm function based on time to complete 15 tasks performed with each arm. WMFT will be used to assess change in arm function relative to dose of physical therapy.
Motor Activity Log (MAL)
时间窗: Change from Baseline to up to 4 months post-randomization
Semi-structured interview in which participants are asked to rate the quality of movement (QOM) of their more affected arm for 28 activities of daily living. MAL is used to assess changes in participant perspective of arm use in daily life relative to dose of physical therapy.
次要结局
- Stroke Impact Scale (SIS)(Change from Baseline to up to 10 months post-randomization)
- Upper Extremity Fugl-Meyer (UEFM)(Change from Baseline to up to 10 months post-randomization)
- Stroke Impact Scale (SIS)(Change from Baseline to up to 4 months post-randomization)
- Upper Extremity Fugl-Meyer (UEFM)(Change from Baseline to up to 4 months post-randomization)
研究者
Carolee Winstein
Professor
University of Southern California