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Upper Limbs Intervention in Multiple Sclerosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02047825
Enrollment
37
Registered
2014-01-28
Start date
2014-01-31
Completion date
2016-02-29
Last updated
2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Dexterity, Upper limbs

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.

Interventions

OTHERUsual treatment

Occupational therapy and physiotherapy, twice a week, as usual.

OTHERUpper 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.

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in manual dexteritybaseline, 8 weeksChanges 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

MeasureTime frameDescription
Change in fatiguebaseline, 8 weeksThe 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 functioningbaseline, 8 weeksThe 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 strengthbaseline, 8 weeksPinch 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 speedbaseline, 8 weeksThe tapping speed will be measured with the finger tapping test.
Changes in apraxiabaseline, 8 weeksChanges 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 strengthbaseline, 8 weeksThe 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.

Other

MeasureTime frameDescription
Functionalitybaseline, 8 weeksFunctionality 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
Quality of lifeBaseline, 8 weeksQuality of life is going to be measured using a self-reported questionnaire, the short-form Health Survey, SF-36
Goals achievementbaseline, 8 weeksThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026