Critical Periods After Stroke Study (CPASS)
关键词
抽象
描述
Please see the following reference:
Dromerick, A.W., Edwardson, M., Edwards, D.F., Giannetti, M.L., Barth, J., Brady, K.P., Chan, E., Tan, M.T., Tamboli, I., Chia, R., Orquiza, M., Padilla, R.M., Cheema, A.K., Mapstone, M., Fiandaca, M.S., Federoff, H.J., & Newport, E.L. (2015). Critical Periods after Stroke Study: Translating animal stroke recovery experiments into a clinical trial. Frontiers in Human Neuroscience, 9, 002231. PMCID: PMC4413691.
日期
| 最后验证: | 03/31/2020 |
| 首次提交: | 07/13/2014 |
| 提交的预估入学人数: | 09/04/2014 |
| 首次发布: | 09/09/2014 |
| 上次提交的更新: | 04/05/2020 |
| 最近更新发布: | 04/06/2020 |
| 实际学习开始日期: | 08/25/2014 |
| 预计主要完成日期: | 12/30/2020 |
| 预计完成日期: | 01/30/2021 |
状况或疾病
干预/治疗
Behavioral: Acute/Early
Behavioral: Sub-acute/Outpatient
Behavioral: Chronic
Behavioral: Control
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Acute/Early Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke. | Behavioral: Acute/Early Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 30 days of stroke onset. |
| Experimental: Sub-acute/Outpatient Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke. | Behavioral: Sub-acute/Outpatient Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 2 to 3 months post stroke. |
| Experimental: Chronic Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke | Behavioral: Chronic Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 6 to 9 months post stroke. |
| Placebo Comparator: Control Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study. | Behavioral: Control Usual and Customary Care only. No additional therapy will be given during the 1-year study. |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 28 days of admission to inpatient rehabilitation (allows those randomized to the early arm to begin study-related treatment within 30 days) - Age >21 years - Able to participate in first study-related treatment session within 30 days of stroke onset - Able to participate in all study-related activities, including one year follow up and blood draws - Persistent hemiparesis leading to impaired upper extremity function. Hemiparesis as indicated by NIHSS Motor Arm score ≥ 1 - Recovering moderate motor impairment at the shoulder and elbow or hand such as: - Proximal UE voluntary activity indicated by a score of ≥ 3 on the upper arm item of the Motor Assessment Scale - wrist and finger movement is not required or - Manual Muscle Test (MMT) score of ≥ 2 on shoulder flexion or abduction and MMT score of ≥ 2 for any of the following: elbow flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger extension. or - Active range of motion (AROM) to at least 50% of range in gravity eliminated position for shoulder flexion or abduction, and for any of the following motions: elbow flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger extension. - Score of ≤ 8 on the Short Blessed Memory Orientation and Concentration Scale - Follows 2 step commands - No upper extremity injury or conditions that limited use prior to the stroke - Pre-stroke independence: Modified Rankin Score 0 or 1 Exclusion Criteria: - Inability to give informed consent - Prior stroke with persistent motor impairment or other disabling neurologic condition such as multiple sclerosis, parkinsonism, amyotrophic lateral sclerosis (ALS), dementia requiring medication - Rapidly improving motor function - Clinically significant fluctuations in mental status in the 72 hours prior to randomization - Hemispatial neglect as determined by >3 errors on the Mesulam Symbol Cancellation Test - Not independent prior to stroke (determined by scores of <95 on Barthel Index or >1 on Modified Rankin Scale - Dense sensory loss indicated by a score of 2 on NIHSS sensory item - Ataxia out of proportion to weakness in the affected arm as described by a score of ≥ 1 on the NIHSS limb ataxia item - Active or prior psychosis within 2 years - Active or prior (within 2 years) substance abuse - Not expected to survive 1 year due to other illnesses (cardiac disease, malignancy, etc) - Received upper extremity botulinum toxin within 6 months (other medications do not exclude) |
结果
主要结果指标
1. Action Research Arm Test (ARAT) [Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke]
次要成果指标
1. Motor Activity Log - 28 Quality of Movement (MAL-28 QOM) [Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke]
2. Nine Hole Peg Test (9-HPT) [Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke]
3. Functional Independence Measure (FIM) [Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke]
4. Barthel Index (BI) [Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke]
5. Motricity Index - Arm only (MI) [Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke]
6. Perception of change (POC) [Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke]
7. Stroke Impact Scale - Hand-Arm subscale (SIS) [Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke]
8. Modified Rankin Scale (MRS) [Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke]
9. Activity Card Sort (ACS) [Pre-treatment (ideally within 72 hours of baseline), post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke]
10. Reintegration to Normal Living Index (RNLI) [Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke]
11. Geriatric Depression Scale (GDS-15) [Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke]
12. NIH Stroke Scale (NIHSS) [Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke]
13. Short Blessed Orientation and Memory Concentration Test (SBT) [Baseline (within 30 days post stroke)]
14. Mesulam Symbol Cancellation Test (SCT) [Baseline (within 30 days post stroke)]
15. Faces Pain Scale [Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke]
16. Fugl Meyer Assessment (Upper Extremity) [Baseline (within 30 days post stroke) and 1 year post stroke]
17. Manual Muscle Test (Upper Extremity) [Baseline (within 30 days post stroke)]
其他成果措施
1. Motor Assessment Scale - Upper Arm Function (MAS) [Baseline (within 30 days of stroke onset)]
