Upper Limbs Intervention in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047825
• Other study ID #: DF0048UG
• Status: Completed
• Phase: N/A
• First received: January 26, 2014
• Last updated: October 30, 2016
• Start date: January 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• Usual treatment
Occupational therapy and physiotherapy, twice a week, as usual.

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Ortiz-Rubio A, Cabrera-Martos I, Rodríguez-Torres J, Fajardo-Contreras W, Díaz-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 Jun 22. pii: S0003-9993(16)30255-6. doi: 10.1016/j.apmr.2016.05.018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Quality of life is going to be measured using a self-reported questionnaire, the short-form Health Survey, SF-36	Baseline, 8 weeks	Yes
Other	Goals achievement	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.	baseline, 8 weeks	Yes
Other	Functionality	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	baseline, 8 weeks	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Tapping speed	The tapping speed will be measured with the finger tapping test.	baseline, 8 weeks	Yes