Upper Limbs Intervention in Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT02047825|
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: Upper limbs intervention Other: Usual treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Intervention Focused on Lower Limbs and Functionality in Patients With Multiple Sclerosis|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||February 2016|
Experimental: Experimental group
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.
Other: Upper limbs intervention
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.
Other Name: Exercise program
Active Comparator: Control group
Patients with multiple sclerosis not included in the intensive intervention. They receive the usual treatment of occupational and physical therapy.
Other: Usual treatment
Occupational therapy and physiotherapy, twice a week, as usual.
Other Name: Standard treatment
- 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.
- Changes in apraxia [ Time Frame: baseline, 8 weeks ]Changes in apraxia from baseline to postintervention is going to be measured using the Apraxia Screen of Tulia. This is a screening test of upper limbs apraxia.
- Changes in grip strength [ Time Frame: baseline, 8 weeks ]The changes in the grip strength will be measured using a Jamar dynamometer with a standard protocol allowing three attempts on each side. During each measurement, patients were sitting with their shoulder adducted and elbow flexed to 90°. The maximum value achieved from all six attempts was used in analyses. kg/cm2.
- Change in fatigue [ Time Frame: baseline, 8 weeks ]The fatigue change is going to be measured using the Fatigue Severity Scale, a 9-item scale focus on the severity of fatigue and how much it affects the person's activities and lifestyle in the patients.
- Upper limb functioning [ Time Frame: baseline, 8 weeks ]The upper limb functioning is going to be measured with the Action Research Arm Test, it is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).
- Pinch strength [ Time Frame: baseline, 8 weeks ]Pinch strength is going to be measured using a pinch dynamometer. The participants were asked to perform three repetitions on each side with five seconds rest provided between the measures. This was performed using the alternating-hands method, which allows rest between repetitions as the examiner records information and provides instructions for the alternate hand. Three pinchs were evaluated: lateral, distal and tripod pinch
- Tapping speed [ Time Frame: baseline, 8 weeks ]The tapping speed will be measured with the finger tapping test.
- Quality of life [ Time Frame: Baseline, 8 weeks ]Quality of life is going to be measured using a self-reported questionnaire, the short-form Health Survey, SF-36
- Goals achievement [ Time Frame: baseline, 8 weeks ]The achievement of the goals of the intervention will be measured with the Goal Attainment Scale, a method of scoring the extent to which patient's individual goals are achieved in the course of intervention.
- Functionality [ Time Frame: baseline, 8 weeks ]Functionality will be measured with the Functional Independence Measure, a questionnaire. This is the most widely accepted functional assessment measure in use in the rehabilitation community
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047825
|Faculty of Health Sciences|
|Granada, Spain, 18071|
|Principal Investigator:||Marie Carmen Valenza, PhD||Universidad de Granada|