Skip to main content
OpenTrials
Completed

NCT Number: NCT03608527

Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Passive upper limb mobilization

Behavioral

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

Primary outcomes

  1. Change in the time to perform the Nine Hole Peg Test (NHPT)

    Time frame: 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 outcomes

  1. Score obtained at the Action Research Arm Test (ARAT)

    Time frame: 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.

  2. Grip and pinch strength

    Time frame: Baseline and 8 weeks

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

  3. Brain activity (blood-oxygenation-level dependent signal)

    Time frame: Baseline and 8 weeks

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

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Sclerosi Multipla

Other

Collaborators

  • Universita degli Studi di Genova

Registry information

Official study title

The Impact of Motor Rehabilitation on the Dynamic Properties of the Brain: Towards the Individual Tailoring of Therapeutic Interventions in Multiple Sclerosis Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 1, 2018
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.