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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03608527
Other study ID # FISM 2011R8
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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