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Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

Not Applicable
Completed
Conditions
Multiple Sclerosis
Interventions
Behavioral: Passive upper limb mobilization
Behavioral: Voluntary-based upper limb motor rehabilitation
Registration Number
NCT03608527
Lead Sponsor
Fondazione Italiana Sclerosi Multipla
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Passive motor treatment (PMT) groupPassive upper limb mobilization15 people with multiple sclerosis performing a 8 week passive mobilization delivered by a physical therapist (3 sessions/week).
Active motor treatment (AMT) groupVoluntary-based upper limb motor rehabilitation15 people with multiple sclerosis performing a 8 week rehabilitative treatment based on task-oriented voluntary exercises (3 sessions/week).
Primary Outcome Measures
NameTimeMethod
Change in the time to perform the Nine Hole Peg Test (NHPT)Baseline and 8 weeks

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
NameTimeMethod
Grip and pinch strengthBaseline and 8 weeks

Force applied by the hand and the fingers measured by means of specific dynamometers

Brain activity (blood-oxygenation-level dependent signal)Baseline and 8 weeks

Task-related brain activations assessed by means of functional magnetic resonance imaging during a finger-to-thumb opposition sequence

Score obtained at the Action Research Arm Test (ARAT)Baseline and 8 weeks

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.

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