Clinical trial NCT02047825: Upper Limbs Intervention in Multiple Sclerosis
Official title: Intervention Focused on Lower Limbs and Functionality in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Dexterity
Upper limbs
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in manual dexterity
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Changes in apraxia
timeFrame: baseline, 8 weeks
measure: Changes in grip strength
timeFrame: baseline, 8 weeks
measure: Change in fatigue
timeFrame: baseline, 8 weeks
measure: Upper limb functioning
timeFrame: baseline, 8 weeks
measure: Pinch strength
timeFrame: baseline, 8 weeks
measure: Tapping speed
timeFrame: baseline, 8 weeks
Other outcomes:
measure: Quality of life
timeFrame: Baseline, 8 weeks
measure: Goals achievement
timeFrame: baseline, 8 weeks
measure: Functionality
timeFrame: baseline, 8 weeks
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ortiz-Rubio A, Cabrera-Martos I, Rodriguez-Torres J, Fajardo-Contreras W, Diaz-Pelegrina A, Valenza MC. Effects of a Home-Based Upper Limb Training Program in Patients With Multiple Sclerosis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Dec;97(12):2027-2033. doi: 10.1016/j.apmr.2016.05.018. Epub 2016 Jun 22.