Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608527
• Other study ID #: FISM 2011R8
• Status: Completed
• Phase: N/A
• Start date: September 9, 2013
• Est. completion date: March 4, 2015

Study information

• Verified date: July 2018
• Source: Fondazione Italiana Sclerosi Multipla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 4, 2015
• Est. primary completion date: December 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• 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.
• Passive upper limb mobilization
Passive mobilization delivered by a physical therapist of shoulder, elbow, wrist and fingers without detectable muscle activity.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Italiana Sclerosi Multipla	Universita degli Studi di Genova

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and 8 weeks
Secondary	Grip and pinch strength	Force applied by the hand and the fingers measured by means of specific dynamometers	Baseline and 8 weeks
Secondary	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	Baseline and 8 weeks