NCT04165616 Motor rECovery witH eArly imagiNg In STroke
| NCT ID | NCT04165616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-06-21 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2022-06-21 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will contribute to the field of stroke rehabilitation research by expanding the investigator's understanding of the neural mechanisms responsible for the development and expression of abnormal flexion synergy, a primary movement impairment due to stroke. The study will longitudinally evaluate motor tract morphology and motor impairment/function in an attempt to develop early neuroimaging-based predictors of the development of flexion synergy and its impact on reaching and hand recovery (6 month). The study will utilize quantitative motor testing (kinematics and kinetics) to measure motor impairment and reaching and hand function. Both neuroimaging and quantitative motor testing will be conducted within 96 hours-, 2 weeks-, 3 months-, and 6 months-post stroke. The knowledge gained by this study will provide crucial structural and functional neuroimaging evidence that demonstrates the timeline of progressive ipsi- and contralesional motor pathway (including bulbospinal pathways) changes and the associated development of flexion synergy that grossly impacts reaching and hand function in individuals with moderate to severe stroke.
Eligibility Criteria
Inclusion Criteria: 1. Stroke within the middle cerebral artery distribution based on brain MRI done within 48 hours of admission 2. 18 to 85 years old 3. Isolated motor deficits (hemiparesis) without significant aphasia, visual disturbances, or neglect based on the following scores on the NIH Stroke Scale: 1a (level of consciousness) = 0- Alert; keenly responsive. 1b (LOC questions) = 0- Asked month and age; Answers both correctly. 1c (LOC commands) = 0- Asked to open/close eyes, grasp/release hand; Performs both correctly. 2 (Best Gaze) = 0- Horizontal eye movements; Normal. 5 (Motor Arm) = 1, 2, 3, or 4- Arm placed at 90 (sitting) or 45 (supine), Drift, Some effort, No effort against gravity, or No movement. 7 (Limb Ataxia) = 0- Finger-nose-finger or heel-shin test; Absent. 8 (Sensory) = 0 or 1- Pin prick; Normal or Mild-to-moderate sensory loss. 9 (Best Language) = 0 or 1- Describe picture; No or Mild-to-moderate Aphasia. 11 (Extinction and Inattention) = 0 or 1- No abnormality or Inattention to one modality. Exclusion Criteria: 1. Premorbid disability or sensorimotor impairment 2. Comorbidity medically contraindicating the administration of subsequent MRI scanning and motor assessments 3. Pain or hypersensitivity limiting motor assessment 4. Limb edema limiting motor assessment
Contact & Investigator
Julius PA Dewald, PT, PhD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT04165616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04165616 currently recruiting?
Yes, NCT04165616 is actively recruiting participants. Contact the research team at m-ellis@northwestern.edu for enrollment information.
Where is the NCT04165616 trial being conducted?
This trial is being conducted at Chicago, United States, Chicago, United States, Chicago, United States.
Who is sponsoring the NCT04165616 clinical trial?
NCT04165616 is sponsored by Northwestern University. The principal investigator is Julius PA Dewald, PT, PhD at Northwestern University. The trial plans to enroll 120 participants.
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