Clinical Features and Rehabilitation Effect in Patients With Stroke

NCT05478577 | Completed

• 1 other identifier: PCR 2021.20
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

rehabilitation; upper limb; cognitive functions; motor function

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment Upper Extremity

  Fugl-Meyer Assessment Upper Extremity is a stroke-specific scale which assesses the upper limb motor functioning in patients with post-stroke hemiplegia. There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to upper limb hemiplegia. The maximum value is 66 points, which corresponds to normal motor performance.

  change from baseline up to 8 weeks

Secondary Outcomes (6)

• Oxford Cognitive Screen

  at baseline

• Reaching Performance Scale

  Change from baseline up to 8 weeks.

• Box & Blocks Test

  Change from baseline up to 8 weeks.

• Modified Ashworth Scale

  Change from baseline up to 8 weeks.

• Functional Independence Measure

  Change from baseline up to 8 weeks.

Interventions

Motor rehabilitation OTHER

Treatments for upper limb recovery (e.g. occupational therapy, technology devices, conventional therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with stroke hospitalised at San Camillo Hospital for a period of neurological rehabilitation

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

San Camillo IRCCS Hospital

Venezia, Venice, 30126, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: September 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)