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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05423119
Other study ID # Prot. 2021.10
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 19, 2021
Est. completion date February 28, 2024

Study information

Verified date September 2023
Source IRCCS San Camillo, Venezia, Italy
Contact Nicola Filippini, PhD
Phone +39 0412207435
Email nicola.filippini@hsancamillo.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 to provided rehabilitation.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - first ever single stroke - unilateral cortical/subcortical stroke Exclusion Criteria: - other neurological disease - psychiatric disorders - cerebellar stroke

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
conventional therapy
upper limb rehabilitation with and without technologies

Locations

Country Name City State
Italy IRCCSSanCamillo Lido Venezia

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline up to 8 weeks.
Secondary 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 Change from baseline up to 8 weeks.
Secondary 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. Change from baseline up to 8 weeks.
Secondary 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. Change from baseline up to 8 weeks.
Secondary 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). Change from baseline up to 8 weeks.
Secondary Imaging data functional and structural connectivity of the brain Change from baseline up to 8 weeks.
Secondary Presence of Motor Evoked Potentials Presence of Motor Evoked Potentials in the upper limb Change from baseline up to 8 weeks.
Secondary 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). Change from baseline up to 8 weeks
Secondary 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. Change from baseline up to 8 weeks
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