NCT02047825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

January 26, 2014

Last Update Submit

October 30, 2016

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisDexterityUpper limbs

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Changes in apraxia

    baseline, 8 weeks

  • Changes in grip strength

    baseline, 8 weeks

  • Change in fatigue

    baseline, 8 weeks

  • Upper limb functioning

    baseline, 8 weeks

  • Pinch strength

    baseline, 8 weeks

  • +1 more secondary outcomes

Other Outcomes (3)

  • Quality of life

    Baseline, 8 weeks

  • Goals achievement

    baseline, 8 weeks

  • Functionality

    baseline, 8 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: Usual treatment

Interventions

Upper limbs interventionOTHER

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.

Also known as: Exercise program
Experimental group
Usual treatmentOTHER

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

Also known as: Standard treatment
Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with multiple sclerosis.
  • Subjects who can complete the assessment battery of tests at the beginning and at the end of the study

You may not qualify if:

  • Auditive and visual disturbances.
  • Cognitive problems.
  • Psychiatric pathology.
  • Sensorial disturbances.
  • Traumatic pathology of the hand.
  • Concomitant neurological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Granada, Spain, 18071, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27343343BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 26, 2014

First Posted

January 28, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Study Completion

February 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

ES(1)