Clinical Predictors of Rehabilitation-induced Arm Recovery After Stroke: Longitudinal Cohort Study

NCT ID: NCT05423119

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-19

Study Completion Date

2024-02-28

Brief Summary

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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

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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).

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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conventional therapy

upper limb rehabilitation with and without technologies

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* first ever single stroke
* unilateral cortical/subcortical stroke

Exclusion Criteria

* other neurological disease
* psychiatric disorders
* cerebellar stroke
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role lead

Responsible Party

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Nicola Filippini

PHD, Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicola Filippiin

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Camillo, Venezia, Italy

Locations

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IRCCSSanCamillo

Lido, Venezia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Nicola Filippini, PhD

Role: CONTACT

+39 0412207435

Facility Contacts

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Nicola Filippini, PhD

Role: primary

+39 0412207435

Other Identifiers

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Prot. 2021.10

Identifier Type: -

Identifier Source: org_study_id

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