Table 2

Eligibility criteria
INCLUSION
1. Ischemic or hemorrhagic stroke (subdural and epidural effusions permitted) within the previous 106 days
2. Hemiparesis (weakness) in arm or hand
3. Some active finger extension movement by close of enrollment window
4. Age 21+
5. Able to communicate in English
6. Willing to attend outpatient therapy and all study evaluations
EXCLUSION (truncated list)
    Neurologic symptoms or conditions
1. Traumatic or non-vascular brain injury, subarachnoid hemorrhage, AV malformation, acute subdural or epidural hematoma
2. Neurologic condition that may affect motor response (e.g. Parkinson’s, ALS, MS)
3. Presence of ataxia per NIHSS [32] and evidence of cerebellar or brainstem lesion
4. Absent upper extremity sensation per NIHSS
5. Neglect asymmetry > 3 per Mesulam Unstructured [33]
6. A second stroke within the last 72 hours cannot be ruled out before the brief medical exam (BME)
    Physical attributes affecting movement or function
1. Total UE Fugl-Meyer score <19 or >58, or = 0 for finger mass extension/grasp release hand score
2. UE pain that substantially interferes with ADL’s
3. Maximum assistance required for mobility
4. Passive ROM limitation of the hemiparetic upper extremity that prevents functional use of limb/hand, including any of the following:
    1. Shoulder: flexion <90°, abduction <90°, external rotation <45°
    2. Elbow/Forearm: extension <−20°, supination or pronation < 45° from neutral
    3. Wrist/Finger: flexion or extension <0°, MCP or IP extension <30°
    Pre-morbid status
1. Head trauma requiring > 48 hours of hospitalization within past 12 mos.
2. Psychiatric illness requiring hospitalization within past 24 mos.
3. Arm or hand injury limiting use prior to stroke
4. Amputation of all fingers or thumb of affected hand
5. Pre-morbid motor impairment of the contralateral upper extremity of neurologic origin
6. Barthel Index [10] < 95
    Medication, Drug and/or Alcohol
1. Active or recent drug treatment for dementia
2. Treated with Botox in affected arm within last 3 months
3. Toxicology screen positive for illegal substances or reported use within the past 3 years
4. Reported alcohol use per CAGE or treatment for withdrawal since index stroke
    Cognition and Participation
1. Enrollment in a conflicting study
2. Expected inability to participate in study due to illness, social, or geographic reasons
3. Unable to follow a 2-step command per NIHSS
4. < 2 on the Mini-Cog [34] with an abnormal Clock Draw Test (CDT) [35] or score = 0
5. PHQ-9 total score between 10 and 19 without management plan or score >19
6. Judged medically unstable and/or unable to participate by primary physician or SPI
    Other
1. Received > 6 hours of Outpatient Occupational Therapy (OT) since stroke (Home Health and OT Evaluation do not count toward 6 hour maximum)
2. Clinician’s best judgment (multiple factors in combination): The SPI and CSC concur that the PP is NOT a candidate for randomization

Winstein et al.

Winstein et al. BMC Neurology 2013 13:5   doi:10.1186/1471-2377-13-5

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