Clinical trial NCT05423119: Clinical Predictors of Rehabilitation-induced Arm Recovery After Stroke: Longitudinal Cohort Study
Official title: Investigation of Neurophysiological Substrates and Clinical Behaviour for Prognosis of Rehabilitation-induced Upper Limb Recovery After Stroke: Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: rehabilitation
upper limb
prognosis
neurophysiology
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients undergoing upper limb rehabilitation

Brief summary: Clinical predictors of rehabilitation-induced arm recovery after stroke are still missing since literature provides evidence mainly on the spontaneous recovery path. This longitudinal cohort study aims to identify neurophysiological and behavioural features able to predict arm recovery and how it can change according to provided rehabilitation.

Detailed description: Rationale: evidence suggests that integrity of the Cortico-Spinal Tract (CST), valid Motor Evoked Potentials (MEPs), age and neurological status are positive prognostic features for better recovery. Concurrently, dosage of rehabilitation therapy is a key factor in promoting functional recovery. However, there are no evidence suggesting whether dose of rehabilitation also influence prediction of UL motor recovery after stroke.

Aims: to define (i) predictive features for rehabilitation-induced UL recovery and (ii) the effect of rehabilitation doses.

Methods: stroke patients will be longitudinally enrolled and assessed with Magnetic Resonance Imaging, Transcranial Magnetic Stimulation (TMS), blood sample and clinical outcome measures at the beginning (T0) of rehabilitation and after 8 weeks (T1).

Eligibility criteria: Inclusion Criteria:

* first ever single stroke
* unilateral cortical/subcortical stroke

Exclusion Criteria:

* other neurological disease
* psychiatric disorders
* cerebellar stroke

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: Change from baseline up to 8 weeks.
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: Change from baseline up to 8 weeks.
measure: Reaching Performance Scale
timeFrame: Change from baseline up to 8 weeks.
measure: Box & Blocks Test
timeFrame: Change from baseline up to 8 weeks.
measure: Medical Research Council
timeFrame: Change from baseline up to 8 weeks.
measure: Imaging data
timeFrame: Change from baseline up to 8 weeks.
measure: Presence of Motor Evoked Potentials
timeFrame: Change from baseline up to 8 weeks.
measure: Modified Ashworth Scale
timeFrame: Change from baseline up to 8 weeks
measure: Functional Independence Measure
timeFrame: Change from baseline up to 8 weeks
Other outcomes:
Locations:
city: Lido
country: Italy
facility: IRCCSSanCamillo
state: Venezia
Study officials:
affiliation: IRCCS San Camillo, Venezia, Italy
name: Nicola Filippiin
role: PRINCIPAL_INVESTIGATOR
References: