Clinical trial NCT05478577: Clinical Features and Rehabilitation Effect in Patients With Stroke
Official title: Clinical Features and Rehabilitation Effect for Upper Limb Recovery in Patients With Stroke: Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: rehabilitation
upper limb
cognitive functions
motor function
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with stroke hospitalised at San Camillo Hospital for a period of neurological rehabilitation

Brief summary: Dosage of rehabilitation therapy is a key factor in promoting motor functional recovery after stroke. To date, what is not yet known are the clinical features (e.g. the neurological profile, clinical history, motor, language and cognitive abilities), which allow the clinician to predict the recovery potential of a patient before rehabilitation, based on both the initial assessment and the various treatment pathways available in the National Health System. For these reasons, the study aims to explore clinical features and potential effect of rehabilitation dose that could influence upper limb motor recovery

Detailed description: Dosage of rehabilitation therapy is a key factor in promoting motor functional recovery after stroke. Moreover, even though recent evidence has shown that cognitive abilities may support motor recovery, the relationship between cognitive-linguistic and motor skills in stroke patients is still a matter of research. Regarding the dose of intervention, in trials in which patients underwent 6 hours of rehabilitation per day, functional improvements in the upper limb reached clinically relevant levels, up to a difference of 8-11 points on the Fugl-Meyer Upper Extremity. To date, evidence of clinical (e.g. motor, cognitive-linguistic and neurological) and rehabilitation features that may influence upper limb recovery are still missing. Therefore, this study aims to retrospectively explore whether there is a relationship between clinical features and upper limb recovery after rehabilitation in stroke patients.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* first-ever unilateral cortical-subcortical stroke, (ischemic or haemorrhagic)
* completed at least 4 weeks of rehabilitation
* preserved ability or possibility to provide informed consent.

Exclusion Criteria:

* cerebellar or bilateral stroke
* unstable medical conditions;
* diagnosis of other neurological and/or psychiatric diseases in addition to stroke;
* traumatic brain injury;
* not released informed consent

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity
timeFrame: change from baseline up to 8 weeks
Secondary outcomes:
measure: Oxford Cognitive Screen
timeFrame: at baseline
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: Modified Ashworth Scale
timeFrame: Change from baseline up to 8 weeks.
measure: Functional Independence Measure
timeFrame: Change from baseline up to 8 weeks.
measure: Dose of therapy
timeFrame: hospitalisation period (8 weeks)
Other outcomes:
Locations:
city: Venezia
country: Italy
facility: San Camillo IRCCS Hospital
state: Venice
Study officials:
References: