Correlation Between Clinical Neurological Biomarkers and Rehabilitation Outcome
ConditionStroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele Roma
About this trial
Our study purpose is to evaluate the predictive power of various clinical, neurophysiological, and neuroimaging biomarkers-acquired and analyzed using advanced and integrated techniques-on motor functional recovery and disability post-stroke. The goal is to construct an integrated individual biomarker algorithm with a high predictive value for outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
First stroke in the middle cerebral artery territory.
Ischemic or hemorrhagic stroke (7-30 days post-acute event).
Upper limb plegia or paresis.
Both genders, aged >18 years.
Disqualifiers
Previous stroke.
Stroke in territories other than the middle cerebral artery.
Inability to provide informed consent.
Contraindications to TMS or MRI.
Trial population
The study will be conducted in the Neuromotor Rehabilitation Units (Modules A-B-C) of IRCCS San Raffaele Pisana, Rome, Italy
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
change in arm Fugl-Meyer score
assess the predictive power of biomarkers, individually or in combination, on the Fugl-Meyer Upper Limb Motor Scale (FM-UL) score at two months post-rehabilitation admission and at 4-6 months post-discharge
Time frame
at T0 (from 14 to 30 days post-stroke), T1 (after 2 months of intensive rehabilitation treatment) and T2 (4-6 months after discharge).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov