Upper Limbs Intervention in Multiple Sclerosis

NCT ID: NCT02047825

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-02-29

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.

Conditions

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Multiple Sclerosis

Keywords

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Multiple sclerosis Dexterity Upper limbs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Upper limbs intervention

Intervention Type OTHER

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.

Control group

Patients with multiple sclerosis not included in the intensive intervention. They receive the usual treatment of occupational and physical therapy.

Group Type ACTIVE_COMPARATOR

Usual treatment

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Usual treatment

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

Intervention Type OTHER

Other Intervention Names

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Exercise program Standard treatment

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Marie Carmen Valenza

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie Carmen Valenza, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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Faculty of Health Sciences

Granada, Spain, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 27343343 (View on PubMed)

Other Identifiers

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DF0048UG

Identifier Type: -

Identifier Source: org_study_id