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Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Voluntary-based upper limb motor rehabilitation
Passive upper limb mobilization
Sponsored by
Fondazione Italiana Sclerosi Multipla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Upper limb motor rehabilitation, Voluntary movements, functional magnetic resonance imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Multiple sclerosis diagnosis according to McDonald criteria
  • right handedness as assessed by the Edinburgh Handedness Inventory
  • absence of relapses in the last three months
  • mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the Medical Research Council scale (grade 3-4)

Exclusion Criteria:

  • steroid-use or a worsening of the Expanded Disability Status Scale (EDSS) score in the last three months
  • psychiatric disorders
  • severe cognitive impairment
  • magnetic resonance imaging contraindications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Active motor treatment (AMT) group

    Passive motor treatment (PMT) group

    Arm Description

    15 people with multiple sclerosis performing a 8 week rehabilitative treatment based on task-oriented voluntary exercises (3 sessions/week).

    15 people with multiple sclerosis performing a 8 week passive mobilization delivered by a physical therapist (3 sessions/week).

    Outcomes

    Primary Outcome Measures

    Change in the time to perform the Nine Hole Peg Test (NHPT)
    The NHPT is a brief, standardized, quantitative test of upper extremity function, requiring participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible.

    Secondary Outcome Measures

    Score obtained at the Action Research Arm Test (ARAT)
    The Action Research Arm Test is an observational measure used to assess upper extremity performance (coordination, dexterity and functioning). The scale ranges from 0 to 57, with higher scores indicating better outcomes. Items are categorized into four subscales: grasp (score 0-18) , grip (0-12), pinch (0-18) and gross movement (0-9) which are arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task.
    Grip and pinch strength
    Force applied by the hand and the fingers measured by means of specific dynamometers
    Brain activity (blood-oxygenation-level dependent signal)
    Task-related brain activations assessed by means of functional magnetic resonance imaging during a finger-to-thumb opposition sequence

    Full Information

    First Posted
    July 13, 2018
    Last Updated
    July 24, 2018
    Sponsor
    Fondazione Italiana Sclerosi Multipla
    Collaborators
    Universita degli Studi di Genova
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03608527
    Brief Title
    Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
    Official Title
    The Impact of Motor Rehabilitation on the Dynamic Properties of the Brain: Towards the Individual Tailoring of Therapeutic Interventions in Multiple Sclerosis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 9, 2013 (Actual)
    Primary Completion Date
    December 22, 2014 (Actual)
    Study Completion Date
    March 4, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Italiana Sclerosi Multipla
    Collaborators
    Universita degli Studi di Genova

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. For example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. However, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined. Moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks. Therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. Particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Upper limb motor rehabilitation, Voluntary movements, functional magnetic resonance imaging

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active motor treatment (AMT) group
    Arm Type
    Experimental
    Arm Description
    15 people with multiple sclerosis performing a 8 week rehabilitative treatment based on task-oriented voluntary exercises (3 sessions/week).
    Arm Title
    Passive motor treatment (PMT) group
    Arm Type
    Active Comparator
    Arm Description
    15 people with multiple sclerosis performing a 8 week passive mobilization delivered by a physical therapist (3 sessions/week).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Voluntary-based upper limb motor rehabilitation
    Intervention Description
    Exercises for neuromuscular control to improve proprioceptive sensibility, muscle strength, stability and coordination of the upper limbs, mainly including task-oriented movements with the goal to improve activities of daily living. Both proximal and distal muscles are involved, in actions such as grasping wooden cubes of different sizes, pinching, reaching targets displayed in front of the patient, and doing patchwork or paper mandala.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Passive upper limb mobilization
    Intervention Description
    Passive mobilization delivered by a physical therapist of shoulder, elbow, wrist and fingers without detectable muscle activity.
    Primary Outcome Measure Information:
    Title
    Change in the time to perform the Nine Hole Peg Test (NHPT)
    Description
    The NHPT is a brief, standardized, quantitative test of upper extremity function, requiring participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible.
    Time Frame
    Baseline and 8 weeks
    Secondary Outcome Measure Information:
    Title
    Score obtained at the Action Research Arm Test (ARAT)
    Description
    The Action Research Arm Test is an observational measure used to assess upper extremity performance (coordination, dexterity and functioning). The scale ranges from 0 to 57, with higher scores indicating better outcomes. Items are categorized into four subscales: grasp (score 0-18) , grip (0-12), pinch (0-18) and gross movement (0-9) which are arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task.
    Time Frame
    Baseline and 8 weeks
    Title
    Grip and pinch strength
    Description
    Force applied by the hand and the fingers measured by means of specific dynamometers
    Time Frame
    Baseline and 8 weeks
    Title
    Brain activity (blood-oxygenation-level dependent signal)
    Description
    Task-related brain activations assessed by means of functional magnetic resonance imaging during a finger-to-thumb opposition sequence
    Time Frame
    Baseline and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Multiple sclerosis diagnosis according to McDonald criteria right handedness as assessed by the Edinburgh Handedness Inventory absence of relapses in the last three months mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the Medical Research Council scale (grade 3-4) Exclusion Criteria: steroid-use or a worsening of the Expanded Disability Status Scale (EDSS) score in the last three months psychiatric disorders severe cognitive impairment magnetic resonance imaging contraindications
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marco Bove, Prof
    Organizational Affiliation
    Universita degli Studi di Genova
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

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