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StrokeNeuroProNCT05423119

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

An observational study of Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
conventional therapy
How many people
75 participants
Where
1 siteItaly
Study dates
19 Aug 2021to 28 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Stroke patients undergoing upper limb rehabilitation

Who may be able to join

  • first ever single stroke
  • unilateral cortical/subcortical stroke

Who cannot join

  • other neurological disease
  • psychiatric disorders
  • cerebellar stroke

Trial locations and contacts

1 site in 1 country.

Nicola Filippini, PhD contact

+39 0412207435

nicola.filippini@hsancamillo.it

Italy1 site, 1 recruiting

  • IRCCSSanCamillo

    Lido, Venezia, 30126

    Nicola Filippini, PhD, +39 0412207435, nicola.filippini@hsacamillo.it

    Recruiting

Other trials in Italy

About this study

Official title: Investigation of Neurophysiological Substrates and Clinical Behaviour for Prognosis of Rehabilitation-induced Upper Limb Recovery After Stroke: Longitudinal Cohort Study

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.

Read the 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).

Conditions
Stroke
Keywords
rehabilitation, upper limb, prognosis, neurophysiology
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assessment

    Fugl-Meyer 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.

    Measured: Change from baseline up to 8 weeks.

Secondary outcomes (8)

  1. Action Research Arm Test

    ARAT is a stroke-specific scale which assesses the upper limb motor activities. The maximum value is 57 and corresponds to normal motor performance

    Measured: Change from baseline up to 8 weeks.

  2. Reaching Performance Scale

    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.

    Measured: Change from baseline up to 8 weeks.

  3. Box & Blocks Test

    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.

    Measured: Change from baseline up to 8 weeks.

  4. Medical Research Council

    The scale assess motor strength for each muscle tested. The score goes from 0 (no muscle contraction) to 5 (normal muscle strength against high resistance).

    Measured: Change from baseline up to 8 weeks.

  5. Imaging data

    functional and structural connectivity of the brain

    Measured: Change from baseline up to 8 weeks.

  6. Presence of Motor Evoked Potentials

    Presence of Motor Evoked Potentials in the upper limb

    Measured: Change from baseline up to 8 weeks.

  7. Modified Ashworth Scale

    Spasticity is measured using the Modified Ashworth Scale of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points). The therapist evaluates the spasticity of each muscles. 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).

    Measured: Change from baseline up to 8 weeks

  8. Functional Independence Measure

    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.

    Measured: Change from baseline up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start19 Aug 2021
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion28 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05423119
Sponsor's protocol ID
Prot. 2021.10
Acronym
NeuroPro
Status last verified
Sep 2023
First submitted
10 Jun 2022
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicola Filippini, PhD (+39 0412207435, nicola.filippini@hsancamillo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment (time frame: Change from baseline up to 8 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05423119.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.

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