Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis

November 10, 2016 updated by: Fondazione Don Carlo Gnocchi Onlus

Effects of Neurorehabilitation on Upper Limb Performance and on Fatigue in People With Multiple Sclerosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20148
        • Fondazione Don Gnocchi ONLUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: Baseline
No intervention is planned

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in 9-hole peg test at 2 and 4 months
Time Frame: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
Change from Baseline in Heart Rate at 2 and 4 months
Time Frame: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

University of Genova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 10, 2016

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UL_SM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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