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Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Task Oriented rehabilitation and aerobic training

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fondazione Don Gnocchi ONLUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neurorehabilitation

Baseline

Arm Description

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.

No intervention is planned

Outcomes

Primary Outcome Measures

Change from Baseline in 9-hole peg test at 2 and 4 months

Change from Baseline in Heart Rate at 2 and 4 months

Secondary Outcome Measures

Full Information

NCT ID

NCT02960984

First Posted

November 8, 2016

Last Updated

November 10, 2016

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

University of Genova

1. Study Identification

Unique Protocol Identification Number

NCT02960984

Brief Title

Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

University of Genova

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neurorehabilitation

Arm Type

Experimental

Arm Description

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.

Arm Title

Baseline

Arm Type

No Intervention

Arm Description

No intervention is planned

Intervention Type

Other

Intervention Name(s)

Task Oriented rehabilitation and aerobic training

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Davide Cattaneo, PhD

Phone

+390240308

Ext

814

dcattaneo@dongnocchi.it

Facility Information:

Facility Name

Fondazione Don Gnocchi ONLUS

City

Milan

ZIP/Postal Code

20148

Country

Italy

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Davide Cattaneo, PhD

First Name & Middle Initial & Last Name & Degree

Davide Cattaneo, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis

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