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Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03608527
Enrollment
30
Registered
2018-08-01
Start date
2013-09-09
Completion date
2015-03-04
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

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

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.

Interventions

BEHAVIORALVoluntary-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.

BEHAVIORALPassive upper limb mobilization

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

Sponsors

Universita degli Studi di Genova
CollaboratorOTHER
Fondazione Italiana Sclerosi Multipla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the time to perform the Nine Hole Peg Test (NHPT)Baseline and 8 weeksThe 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

MeasureTime frameDescription
Score obtained at the Action Research Arm Test (ARAT)Baseline and 8 weeksThe 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.
Grip and pinch strengthBaseline and 8 weeksForce applied by the hand and the fingers measured by means of specific dynamometers
Brain activity (blood-oxygenation-level dependent signal)Baseline and 8 weeksTask-related brain activations assessed by means of functional magnetic resonance imaging during a finger-to-thumb opposition sequence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026