Clinical trial NCT03485040: Stroke Motor Rehabilitation and Recovery Study
Official title: Defining the Trajectory of Motor Recovery After Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Ischemic
Keywords: Rehabilitation
Neurorehabilitation
Neurotechnology
Neurorecovery
Neurorestoration
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are admitted to the Massachusetts General Hospital with upper extremity motor weakness after ischemic and/or hemorrhagic stroke.

Brief summary: SMaHRT (Stroke Motor reHabiliation and Recovery sTudy) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic and hemorrhagic stroke.

Detailed description: Participants will be enrolled in the SMaHRT study during their acute stroke hospitalization and will have research visits spanning the post-stroke care continuum at approximately 6 weeks, 3 months, 6 months, one year, two years, and three years after stroke. The study will collect demographics and clinical outcome measures, clinical neuroimages, video and robot-kinematic data and neurophysiology data through TMS and EEG in order to quantify the course of motor recovery. The research visits may be accompanied by a comprehensive clinical visit to the Massachusetts General Hospital Neurorecovery Clinic. The goal is to understand the behavioral, neuroanatomic, and neurophysiologic underpinnings of motor recovery toward developing personalized strategies and neurotechnologies to facilitate neurorehabilitation and enable better recovery for people with stroke.

Eligibility criteria: Inclusion Criteria

* Age 18 - 90
* Upper extremity motor weakness after ischemic and/or hemorrhagic stroke as defined by a score of \>=1 on NIH Stroke Scale Arm Motor Drift Questions 5A or 5B
* Ability to follow simple commands in English
* Score of zero or 1 on the NIH Stroke Scale Level of Consciousness Questions 1a and 1b and a score of zero on the NIH Stroke Scale Level of Consciousness Question 1c.
* Stable medical status as determined by primary care team
* Inpatient on the MGH stroke neurology service

Exclusion Criteria

* Prior history of developmental, neurologic, or major psychiatric disorder resulting in functional disability
* Prior history of visual or auditory disorders limiting ability to participate in testing
* Evidence of an uncontrolled seizure disorder
* Patients for whom EEG leads are contraindicated

Primary outcomes:
measure: Fugl-Meyer Arm Motor Assessment
timeFrame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A
Secondary outcomes:
Other outcomes:
measure: Barthel Index
timeFrame: Time 1: During acute hospitalization; Time 2: ~ 6 weeks after stroke date; Time 3: ~ 90 days after stroke date; Time 4: ~ 180 days after stroke date; Time 5: ~ 1 year after stroke date Time 6: ~ 2 years after stroke date; Time 7: ~ 3 years after stroke
measure: Pre-Morbid Modified Rankin Score
timeFrame: Time 1: During acute hospitalization; Time 2: N/A; Time 3: N/A; Time 4: N/A; Time 5: N/A Time 6: N/A; Time 7: N/A
measure: Current Modified Rankin Score
timeFrame: Time 1: During acute hospitalization; Time 2: ~ 6 weeks after stroke date; Time 3: ~ 90 days after stroke date; Time 4: ~ 180 days after stroke date; Time 5: ~ 1 year after stroke date Time 6: ~ 2 years after stroke date; Time 7: ~ 3 years after stroke
measure: Patient Health Questionnaire 2 and 9
timeFrame: Time 1: During acute hospitalization; Time 2: ~ 6 weeks after stroke date; Time 3: ~ 90 days after stroke date; Time 4: ~180 days after stroke date; Time 5: ~ 1 year after stroke date Time 6: ~ 2 years after stroke date; Time 7: ~ 3 years after stroke
measure: Stoke Impact Scale 16
timeFrame: Time 1: N/A; Time 2: ~ 6 weeks after stroke date; Time 3: ~90 days after stroke date; Time 4: ~ 180 days after stroke date; Time 5: ~ 1 year after stroke date Time 6: ~ 2 years after stroke date; Time 7: ~ 3 years after stroke
measure: National Institute of Health Stroke Scale
timeFrame: Time 1: During acute hospitalization; Time 2: ~ 6 weeks after stroke date; Time 3: ~ 90 days after stroke date; Time 4: ~ 180 days after stroke date; Time 5: ~ 1 year after stroke date Time 6: ~ 2 years after stroke date; Time 7: ~ 3 years after stroke
measure: Dynamometer
timeFrame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A
measure: Box and Blocks
timeFrame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A
measure: Nine Hole Peg Test
timeFrame: Time Frame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A
measure: Gait Velocity Test
timeFrame: Time Frame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A
measure: Timed Up and Go
timeFrame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A
measure: Overall Impressions of Level of Recovery and Level of Disability
timeFrame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A
measure: PROMIS Scale
timeFrame: Time 1: N/A; Time 2: ~ 6 weeks after stroke date; Time 3: ~ 90 days after stroke date; Time 4: ~ 180 days after stroke date; Time 5: ~ 1 year after stroke date Time 6: ~ 2 years after stroke date; Time 7: ~ 3 years after stroke
measure: Shoulder Abduction / Finger Extension (SAFE)
timeFrame: Time 1: During acute hospitalization; Time 2: ~ 6 weeks after stroke date; Time 3: ~ 90 days after stroke date; Time 4: ~ 180 days after stroke date; Time 5: ~ 1 year after stroke date Time 6: ~ 2 years after stroke date; Time 7: ~ 3 years after stroke
measure: Modified Ashworth Scale (MAS)
timeFrame: Time 1: N/A; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A
measure: Edinburgh Handedness Inventory
timeFrame: Time 1: During acute hospitalization; Time 2: N/A; Time 3: N/A; Time 4: N/A; Time 5: N/A; Time 6: N/A; Time 7: N/A
measure: Rehabilitation Therapy
timeFrame: Time 1: N/A; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A
measure: Functional Ambulation Category (FAC)
timeFrame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Time 1: During acute hospitalization; Time 2: ~ 6 weeks after stroke date; Time 3: ~ 90 days after stroke date; Time 4: ~ 180 days after stroke date; Time 5: ~1 year after stroke date Time 6: ~ 2 years after stroke date; Time 7: ~ 3 years after stroke
measure: Cognitive Linguistic Quick Test (CLQT)
timeFrame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date; Time 6: N/A; Time 7: N/A
measure: Quick Aphasia Battery (QAB)
timeFrame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date; Time 6: N/A; Time 7: N/A
measure: Social Determinants of Health
timeFrame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date; Time 6: N/A; Time 7: N/A
measure: User Participation
timeFrame: Time 1: N/A; Time 2: N/A; Time 3: N/A; Time 4: approx. N/A; Time 5: approx. 1 year after stroke date; Time 6: N/A; Time 7: N/A
measure: 4AT - Rapid Clinical Test for Delirium Detection
timeFrame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date; Time 6: N/A; Time 7: N/A
measure: Sleep Condition Indicator
timeFrame: Time 1: N/A; Time 2: ~ 6 weeks after stroke date; Time 3: ~90 days after stroke date; Time 4: ~ 180 days after stroke date; Time 5: ~ 1 year after stroke date Time 6: ~ 2 years after stroke date; Time 7: ~ 3 years after stroke
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Neurologist
name: David J Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kline DK, Lin DJ, Cloutier A, Sloane K, Parlman K, Ranford J, Picard-Fraser M, Fox AB, Hochberg LR, Kimberley TJ. Arm Motor Recovery After Ischemic Stroke: A Focus on Clinically Distinct Trajectory Groups. J Neurol Phys Ther. 2021 Apr 1;45(2):70-78. doi: 10.1097/NPT.0000000000000350.
citation: Lin DJ, Erler KS, Snider SB, Bonkhoff AK, DiCarlo JA, Lam N, Ranford J, Parlman K, Cohen A, Freeburn J, Finklestein SP, Schwamm LH, Hochberg LR, Cramer SC. Cognitive Demands Influence Upper Extremity Motor Performance During Recovery From Acute Stroke. Neurology. 2021 May 25;96(21):e2576-e2586. doi: 10.1212/WNL.0000000000011992. Epub 2021 Apr 15.
citation: Kuo YL, Lin DJ, Vora I, DiCarlo JA, Edwards DJ, Kimberley TJ. Transcranial magnetic stimulation to assess motor neurophysiology after acute stroke in the United States: Feasibility, lessons learned, and values for future research. Brain Stimul. 2022 Jan-Feb;15(1):179-181. doi: 10.1016/j.brs.2021.12.001. Epub 2021 Dec 7. No abstract available.