Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

NCT ID: NCT03608527

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-09
• Study Completion Date: 2015-03-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active motor treatment (AMT) group

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

Group Type: EXPERIMENTAL

Voluntary-based upper limb motor rehabilitation

Intervention Type: 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.

Passive motor treatment (PMT) group

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

Group Type: ACTIVE_COMPARATOR

Passive upper limb mobilization

Intervention Type: BEHAVIORAL

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

Interventions

Voluntary-based upper limb motor rehabilitation

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

Passive upper limb mobilization

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita degli Studi di Genova

OTHER

Sponsor Role: collaborator

Fondazione Italiana Sclerosi Multipla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Bove, Prof

Role: PRINCIPAL_INVESTIGATOR

Universita degli Studi di Genova

Other Identifiers

FISM 2011R8

Identifier Type: -

Identifier Source: org_study_id