Clinical Features and Rehabilitation Effect in Patients With Stroke (PCR)

August 3, 2022 updated by: Silvia Salvalaggio, IRCCS San Camillo, Venezia, Italy

Clinical Features and Rehabilitation Effect for Upper Limb Recovery in Patients With Stroke: Retrospective Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Venice
      • Venezia, Venice, Italy, 30126
        • San Camillo IRCCS Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment Upper Extremity
Time Frame: change from baseline up to 8 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reaching Performance Scale
Time Frame: Change from baseline up to 8 weeks.
Reaching Performance Scale assesses the ability of subjects to reach an object (a cone). The cone is placed at both 4-cm (close) and 30-cm (far) distance from the subject. The subject is asked to reach and grab the cone if possible. The observer evaluates the quality of reaching instead of the grip strength. The minimum value is 0 points, which corresponds to incapacity of any ability of reaching an object. The maximum value is 36 points, which corresponds to the preservation of the ability of reaching an object.
Change from baseline up to 8 weeks.
Box & Blocks Test
Time Frame: Change from baseline up to 8 weeks.
The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands.
Change from baseline up to 8 weeks.
Oxford Cognitive Screen
Time Frame: at baseline
Oxford Cognitive Screen is a multidomains screening tool for the assessment of cognitive functions (e.g. attention, executive functions, linguistic functions, memory). For each domain, cut-off scores are calculated according to age and education levels. There is not an overall score, but for each domain pathological performances are identified according to normative data.
at baseline
Modified Ashworth Scale
Time Frame: Change from baseline up to 8 weeks.
Spasticity is measured using the Modified Ashworth Scale of biceps muscle (Total score = 20 points). The therapist evaluates the spasticity of the muscle. There are 5 values: 0 (no increase in muscle tone), 1 (slight increase in muscle tone), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone), 4 (affected part rigid in flexion or extension).
Change from baseline up to 8 weeks.
Functional Independence Measure
Time Frame: Change from baseline up to 8 weeks.
Functional Independence Measure scale is an 18-item scale that assesses the degree of independence in carrying out activities of daily living. There are 7 values: 1 (Total Assistance or not Testable), 2 (Maximal Assistance), 3 (Moderate Assistance), 4 (Minimal Assistance), 5 (Supervision), 6 (Modified Independence), 7 (Complete Independence). The minimum values is 18 points, which corresponds to the lower level of independence in activities of daily living. The maximum value is 126 points, which corresponds to the maximum level of independence in activities of daily living.
Change from baseline up to 8 weeks.
Dose of therapy
Time Frame: hospitalisation period (8 weeks)
Amount (in hours) of rehabilitation that patients underwent during hospitalisation
hospitalisation period (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS San Camillo, Venezia, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCR 2021.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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