Comparing Constraint-Induced Therapy and Occupation-Based Intervention for Optimal Stroke Recovery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- Fugl Meyer Assessment (FMA
研究概览
简要总结
This pilot study was designed to compare the effects of modified constraint-Induced therapy and occupation-based intervention to increase functional motor recovery in stroke
详细描述
The purpose of this study is to investigate change in motor performance and the extent of neuroplastic change associated with both occupation-based intervention and modified constraint-Induced therapy (m-CIT) in the recovery of upper extremity motor function following a stroke. Transcranial Magnetic Imaging (TMS) will be used to compare the difference in the brain reorganization of each client before and after the intervention to identify which technique is more effective in changing brain function. Central Hypothesis: Stroke subjects with motor deficit receiving occupation-based interventions will demonstrate improved motor function greater to that of the subjects receiving m-CIT interventions. Sixteen participants with chronic stroke will be recruited for the study over the age 21. Participants will be randomly assigned to one of the two therapy groups and will receive 55 minutes of therapy 2 times per week for 4 weeks for a total of 8 sessions.
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
- Triple (Participant, Care Provider, 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
- •21 years of age and older
- •at least 12 months from stroke
- •mild-to-severe upper extremity motor deficit
- •single ischemic or hemorrhagic stroke
排除标准
- •history of head injury with loss of consciousness
- •severe alcohol or drug abuse
- •psychiatric illness interfering with participation in the study including uncontrolled depression
- •cognitive deficits severe enough to preclude informed consent
- •ferromagnetic material near the brain
- •individuals that could be pregnant
- •cardiac or neural pacemakers
- •if currently receiving occupational therapy services
结局指标
主要结局
Fugl Meyer Assessment (FMA
时间窗: Score change after 8 days of intervention compared to baseline
次要结局
- Canadian Occupational Performance Measure (COPM)(Score change after 8 days of intervention compared to baseline)
- Stroke Impact Scale (SIS)(Score change after 8 days of intervention compared to baseline)
- Goal Attainment Scale (GAS).(Score change after 8 days of intervention compared to baseline)
- Transcranial Magnetic Stimulation (map volume)(Score change after 8 days of intervention compared to baseline)
研究者
Lumy Sawaki
Associate Professor,department of Physical Medicine and Rehabilitation
University of Kentucky