Critical Periods After Stroke Study (CPASS); Sensitive Periods and Consumer Preferences: Optimizing Upper Extremity Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
To perform an exploratory single center randomized study that will form the basis for a larger scale, more definitive randomized clinical trial to determine the optimal time after stroke for intensive motor training. The investigators will perform a prospective exploratory study of upper extremity (UE) motor training delivered at higher than usual intensity at three different time points after stroke:
- early (initiated within 30 days)
- subacute/outpatient (initiated within 2-3 months)
- chronic (initiated within 6-9 months)
The control group will not receive the therapy intervention during the 1-year study.
Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and one year after stroke onset.
Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or chronic (6-9 months after stroke onset) time points, participants randomized to early intensive motor training will show greater upper extremity motor improvement measured at one year post stroke.
详细描述
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.
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
- 是
入选标准
- •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
- •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.
- •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
排除标准
- •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)
研究组 & 干预措施
Acute/Early
Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke.
干预措施: Early Intensive upper extremity motor training (Behavioral)
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.
干预措施: Sub-acute intensive upper extremity motor training (Behavioral)
Chronic
Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke
干预措施: Chronic intensive upper extremity motor training (Behavioral)
Control
Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study.
干预措施: Control (Behavioral)
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: 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
The ARAT assesses functional limitations and evaluates changes in limb function for the upper extremity.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Geriatric Depression Scale (GDS-15)(Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke)
- Mesulam Symbol Cancellation Test (SCT)(Baseline (within 30 days post stroke))
- 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)
- 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)
- 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)
- Reintegration to Normal Living Index (RNLI)(Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke)
- NIH Stroke Scale (NIHSS)(Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke)
- Short Blessed Orientation and Memory Concentration Test (SBT)(Baseline (within 30 days post stroke))
- 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)
- Manual Muscle Test (Upper Extremity)(Baseline (within 30 days post stroke))
- Fugl Meyer Assessment (Upper Extremity)(Baseline (within 30 days post stroke) and 1 year post stroke)
研究者
Alexander W. Dromerick, MD
Vice President for Research
MedStar National Rehabilitation Network