Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Other: Task Oriented rehabilitation and aerobic training

• Registration Number: NCT02960984
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-10
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-11
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Neurorehabilitation	Task Oriented rehabilitation and aerobic training	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.

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Fondazione Don Gnocchi ONLUS; 🇮🇹 Milan, Italy