Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

NCT03608527 | Completed

• 1 other identifier: FISM 2011R8
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Upper limb motor rehabilitation; Voluntary movements; functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 8 weeks

Secondary Outcomes (3)

• Score obtained at the Action Research Arm Test (ARAT)

  Baseline and 8 weeks

• Grip and pinch strength

  Baseline and 8 weeks

• Brain activity (blood-oxygenation-level dependent signal)

  Baseline and 8 weeks

Study Arms (2)

Active motor treatment (AMT) group

EXPERIMENTAL

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

Behavioral: Voluntary-based upper limb motor rehabilitation

Passive motor treatment (PMT) group

ACTIVE COMPARATOR

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

Behavioral: Passive upper limb mobilization

Interventions

Voluntary-based upper limb motor rehabilitation BEHAVIORAL

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.

Active motor treatment (AMT) group

Passive upper limb mobilization BEHAVIORAL

Passive mobilization delivered by a physical therapist of shoulder, elbow, wrist and fingers without detectable muscle activity.

Passive motor treatment (PMT) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Italiana Sclerosi Multipla: lead
• Universita degli Studi di Genova: collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marco Bove, Prof

  Universita degli Studi di Genova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 1, 2018
• Study Start: September 9, 2013
• Primary Completion: December 22, 2014
• Study Completion: March 4, 2015
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share