Overview

This trial has been completed.

Condition multiple sclerosis
Treatments upper limbs intervention, usual treatment
Sponsor Universidad de Granada
Start date January 2014
End date August 2015
Trial size 37 participants
Trial identifier NCT02047825, DF0048UG

Summary

Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact and economic consequences. It is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. Different areas are affected, including manual dexterity, strength, coordination and function. The objective of this study is to evaluate the improvement in these variables in patients with multiple sclerosis after a 8-weeks intervention focused on upper limbs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
The patients included in this group will receive an intensive intervention based on upper limbs intervention with exercises added to the usual treatment they receive.
upper limbs intervention Exercise program
An 8-week intervention with different exercises will be performed. This intervention will focus on upper limbs. The exercises will include plaster of resistance, elastic bands and other exercises.
(Active Comparator)
Patients with multiple sclerosis not included in the intensive intervention. They receive the usual treatment of occupational and physical therapy.
usual treatment Standard treatment
Occupational therapy and physiotherapy, twice a week, as usual.

Primary Outcomes

Measure
Changes in manual dexterity
time frame: baseline, 8 weeks

Secondary Outcomes

Measure
Changes in apraxia
time frame: baseline, 8 weeks
Changes in grip strength
time frame: baseline, 8 weeks
Change in fatigue
time frame: baseline, 8 weeks
Upper limb functioning
time frame: baseline, 8 weeks
Pinch strength
time frame: baseline, 8 weeks
Tapping speed
time frame: baseline, 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Patients diagnosed with multiple sclerosis. - Subjects who can complete the assessment battery of tests at the beginning and at the end of the study Exclusion Criteria: - Auditive and visual disturbances. - Cognitive problems. - Psychiatric pathology. - Sensorial disturbances. - Traumatic pathology of the hand. - Concomitant neurological conditions

Additional Information

Official title Intervention Focused on Lower Limbs and Functionality in Patients With Multiple Sclerosis
Principal investigator Marie Carmen Valenza, PhD
Description The total estimated prevalence rate of multiple sclerosis has been reported to be 83 per 100 000 for the past three decades. It is also higher in northern countries and between females with a male ratio around 2.0. The highest prevalence rates have been estimated for the age group 35-64 years. The estimated European mean annual Multiple Sclerosis incidence rate is 4.3 cases per 100 000. Multiple sclerosis can cause a variety of symptoms: hypoesthesia, muscle weakness, abnormal muscle spasms, or difficulty moving; difficulties with coordination and balance; dysarthria, dysphagia, visual problems fatigue and acute or chronic pain syndromes, bladder and bowel difficulties,cognitive impairment, or emotional symptomatology. The investigators focus on the benefits of an intervention on dexterity, strength, coordination and functionality.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Universidad de Granada.