Upper Limbs Intervention in Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Upper limbs intervention
* Other: Usual treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* 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.<br>* Other names: Exercise program;|
| Active Comparator: Control group<br>Patients with multiple sclerosis not included in the intensive intervention. They receive the usual treatment of occupational and physical therapy. | Other: Usual treatment<br>* Occupational therapy and physiotherapy, twice a week, as usual.<br>* Other names: Standard treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in manual dexterity | 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. | baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in apraxia | 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. | baseline, 8 weeks | 
| Changes in grip strength | 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. | baseline, 8 weeks | 
| Change in fatigue | 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. | baseline, 8 weeks | 
| Upper limb functioning | 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). | baseline, 8 weeks | 
| Pinch strength | 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 | baseline, 8 weeks | 
| Tapping speed | The tapping speed will be measured with the finger tapping test. | baseline, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexterity, Upper limbs, Multiple sclerosis