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

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
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
NCT ID
NCT03608527
First Posted
July 13, 2018
Last Updated
July 24, 2018
Sponsor
Fondazione Italiana Sclerosi Multipla
Collaborators
Universita degli Studi di Genova
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
Learn more about this trial
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
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