Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis

NCT ID: NCT02960984

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Brief Summary

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In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been shown to exhibit a number of life-altering problems such as fatigue, limb weakness, alteration of upper extremity fine motor coordination, loss of sensation, spasticity. These problems affect performance of many daily living activities (ADL) such as dressing, bathing, self-care, and writing, thus reducing functional independence and self-rated quality of life.

Twenty people with Multiple Sclerosis will receive neurorehabilitation treatment comprising a combination of aerobic training and upper limb task-oriented training.

The aim of this pilot crossover study is to evaluate the effects of neurorehabilitation on upper limb performance and on fatigue in People with Multiple Sclerosis.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Neurorehabilitation

Participants in the experimental group will receive 1 hour treatment comprising 30' of aerobic training on an ergometer and 30' of task-oriented training focused on uppper limb rehabilitation.

Group Type EXPERIMENTAL

Task Oriented rehabilitation and aerobic training

Intervention Type OTHER

Participants in the experimental group will receive 1 hour treatment comprising 30' of aerobic training and 30' of task-oriented training focused on uppper limb rehabilitation for 3 times a week for 20 sessions.

Baseline

No intervention is planned

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Task Oriented rehabilitation and aerobic training

Participants in the experimental group will receive 1 hour treatment comprising 30' of aerobic training and 30' of task-oriented training focused on uppper limb rehabilitation for 3 times a week for 20 sessions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Multiple Sclerosis
* no relapses in the last three months
* Expanded Disability Status Scale (EDSS) ≤ 8;

Exclusion Criteria

* subjects with relapses
* worsening of the pathology in the last three months
* subjects with cognitive and psychiatric disturbances
* subjects with cardiovascular disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Genova

OTHER

Sponsor Role collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Don Gnocchi ONLUS

Milan, , Italy

Site Status

Countries

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Italy

Central Contacts

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Davide Cattaneo, PhD

Role: CONTACT

Phone: +390240308

Email: [email protected]

Facility Contacts

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Davide Cattaneo, PhD

Role: primary

Other Identifiers

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UL_SM

Identifier Type: -

Identifier Source: org_study_id