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Upper Limbs Intervention in Multiple Sclerosis

30. oktober 2016 opdateret af: Marie Carmen Valenza, Universidad de Granada

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

37

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Granada, Spanien, 18071
        • Faculty of Health Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Andre navne:
  • Træningsprogram
Aktiv komparator: Control group
Patients with multiple sclerosis not included in the intensive intervention. They receive the usual treatment of occupational and physical therapy.
Andet: Usual treatment
Occupational therapy and physiotherapy, twice a week, as usual.
Andre navne:
  • Standard behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in manual dexterity
Tidsramme: baseline, 8 weeks
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in apraxia
Tidsramme: baseline, 8 weeks
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
Changes in grip strength
Tidsramme: baseline, 8 weeks
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
Change in fatigue
Tidsramme: baseline, 8 weeks
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
Upper limb functioning
Tidsramme: baseline, 8 weeks
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
Pinch strength
Tidsramme: baseline, 8 weeks
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
Tapping speed
Tidsramme: baseline, 8 weeks
The tapping speed will be measured with the finger tapping test.
baseline, 8 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of life
Tidsramme: Baseline, 8 weeks
Quality of life is going to be measured using a self-reported questionnaire, the short-form Health Survey, SF-36
Baseline, 8 weeks
Goals achievement
Tidsramme: baseline, 8 weeks
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
Functionality
Tidsramme: baseline, 8 weeks
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad de Granada

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2014

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

26. januar 2014

Først indsendt, der opfyldte QC-kriterier

26. januar 2014

Først opslået (Skøn)

28. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DF0048UG

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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