Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02960984
• Other study ID #: UL_SM
• Status: Not yet recruiting
• Phase: N/A
• First received: November 8, 2016
• Last updated: November 10, 2016
• Start date: November 2016

Study information

• Verified date: November 2016
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Davide Cattaneo, PhD
• Phone: +390240308
• Email: dcattaneo[@]dongnocchi.it
• Is FDA regulated: No
• Health authority: Italy: National Istitution of health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione Don Gnocchi ONLUS	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	University of Genova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No