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Trial record 39 of 1650 for:    "Multiple Sclerosis"

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
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Upper limbs intervention Other: Usual treatment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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

  6. Tapping speed [ Time Frame: baseline, 8 weeks ]
    The tapping speed will be measured with the finger tapping test.


Other Outcome Measures:
  1. 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

  2. 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.

  3. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Spain
Faculty of Health Sciences
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Marie Carmen Valenza, PhD Universidad de Granada

Publications:
Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02047825     History of Changes
Other Study ID Numbers: DF0048UG
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marie Carmen Valenza, Universidad de Granada:
Multiple sclerosis
Dexterity
Upper limbs

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases