Upper Limbs Intervention in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Upper limbs intervention
Usual treatment
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Dexterity, Upper limbs
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
Sites / Locations
- Faculty of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
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.
Patients with multiple sclerosis not included in the intensive intervention. They receive the usual treatment of occupational and physical therapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
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
Tapping speed
The tapping speed will be measured with the finger tapping test.
Full Information
NCT ID
NCT02047825
First Posted
January 26, 2014
Last Updated
October 30, 2016
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT02047825
Brief Title
Upper Limbs Intervention in Multiple Sclerosis
Official Title
Intervention Focused on Lower Limbs and Functionality in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Dexterity, Upper limbs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients with multiple sclerosis not included in the intensive intervention. They receive the usual treatment of occupational and physical therapy.
Intervention Type
Other
Intervention Name(s)
Upper limbs intervention
Other Intervention Name(s)
Exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual treatment
Other Intervention Name(s)
Standard treatment
Intervention Description
Occupational therapy and physiotherapy, twice a week, as usual.
Primary Outcome Measure Information:
Title
Changes in manual dexterity
Description
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.
Time Frame
baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Changes in apraxia
Description
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.
Time Frame
baseline, 8 weeks
Title
Changes in grip strength
Description
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.
Time Frame
baseline, 8 weeks
Title
Change in fatigue
Description
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.
Time Frame
baseline, 8 weeks
Title
Upper limb functioning
Description
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).
Time Frame
baseline, 8 weeks
Title
Pinch strength
Description
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
Time Frame
baseline, 8 weeks
Title
Tapping speed
Description
The tapping speed will be measured with the finger tapping test.
Time Frame
baseline, 8 weeks
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
Quality of life is going to be measured using a self-reported questionnaire, the short-form Health Survey, SF-36
Time Frame
Baseline, 8 weeks
Title
Goals achievement
Description
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.
Time Frame
baseline, 8 weeks
Title
Functionality
Description
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
Time Frame
baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences
City
Granada
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27343343
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.
Results Reference
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Upper Limbs Intervention in Multiple Sclerosis
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