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Clinical Trials/NCT02047825
NCT02047825
Completed
Not Applicable

Intervention Focused on Lower Limbs and Functionality in Patients With Multiple Sclerosis

Universidad de Granada1 site in 1 country37 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Universidad de Granada
Enrollment
37
Locations
1
Primary Endpoint
Changes in manual dexterity
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
February 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie Carmen Valenza

assistant professor

Universidad de Granada

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in manual dexterity

Time Frame: baseline, 8 weeks

Changes from baseline to postintervention in manual dexterity assessed by the Purdue Pegboard test and coin rotation task. The Purdue pegboard test is a timed physical test used to measure manual dexterity. Test subjects are asked to place small pins into holes in the pegboard using a specific hand and following a specific process. The coin rotation task consists of rotate the coin during 10 seconds.

Secondary Outcomes

  • Upper limb functioning(baseline, 8 weeks)
  • Changes in apraxia(baseline, 8 weeks)
  • Changes in grip strength(baseline, 8 weeks)
  • Change in fatigue(baseline, 8 weeks)
  • Tapping speed(baseline, 8 weeks)
  • Pinch strength(baseline, 8 weeks)

Study Sites (1)

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