Stroke Motor Rehabilitation and Recovery Study

NCT03485040 | Recruiting

• 1 other identifier: 2017P000868
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

Rehabilitation; Neurorehabilitation; Neurotechnology; Neurorecovery; Neurorestoration

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Arm Motor Assessment

  This test provides information about level of upper extremity motor impairment after stroke. The test includes a series of different movements that allow for the assessment of functional movement capacity and quality. The scale is used to track change in upper extremity motor impairment over the course of one year post stroke.

  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

Other Outcomes (25)

• Barthel Index

  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

• Pre-Morbid Modified Rankin Score

  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

• Current Modified Rankin Score

  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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 33707402 BACKGROUND

• 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.

  PMID: 33858997 BACKGROUND

• 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.

  PMID: 34890840 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David J Lin, MD

  Neurologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie A DiCarlo, MS

CONTACT

617-726-1311; jdicarlo2@mgh.harvard.edu

Maryam Masood, MSC

CONTACT

mmasood@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: April 2, 2018
• Study Start: June 9, 2017
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)