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