Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis

NCT02960984 | Unknown

• 1 other identifier: UL_SM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

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

  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

  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

Study Arms (2)

Neurorehabilitation

EXPERIMENTAL

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

Baseline

NO INTERVENTION

No intervention is planned

Interventions

Task Oriented rehabilitation and aerobic training 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.

Neurorehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• subjects with relapses
• worsening of the pathology in the last three months
• subjects with cognitive and psychiatric disturbances
• subjects with cardiovascular disease

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• University of Genova: collaborator

Study Sites (1)

Fondazione Don Gnocchi ONLUS

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Davide Cattaneo, PhD

CONTACT

+390240308; dcattaneo@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 10, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Last Updated: November 11, 2016

Record last verified: 2016-11

Locations

IT (1)