Upper Limbs Intervention in Multiple Sclerosis
30 oktober 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
37
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Granada, Spanien, 18071
- Faculty of Health Sciences
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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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.
Andra namn:
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Aktiv komparator: Control group
Patients with multiple sclerosis not included in the intensive intervention.
They receive the usual treatment of occupational and physical therapy.
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Occupational therapy and physiotherapy, twice a week, as usual.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes in manual dexterity
Tidsram: baseline, 8 weeks
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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.
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baseline, 8 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes in apraxia
Tidsram: baseline, 8 weeks
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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.
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baseline, 8 weeks
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Changes in grip strength
Tidsram: baseline, 8 weeks
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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.
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baseline, 8 weeks
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Change in fatigue
Tidsram: baseline, 8 weeks
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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.
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baseline, 8 weeks
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Upper limb functioning
Tidsram: baseline, 8 weeks
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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).
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baseline, 8 weeks
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Pinch strength
Tidsram: baseline, 8 weeks
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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
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baseline, 8 weeks
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Tapping speed
Tidsram: baseline, 8 weeks
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The tapping speed will be measured with the finger tapping test.
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baseline, 8 weeks
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Quality of life
Tidsram: Baseline, 8 weeks
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Quality of life is going to be measured using a self-reported questionnaire, the short-form Health Survey, SF-36
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Baseline, 8 weeks
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Goals achievement
Tidsram: baseline, 8 weeks
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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.
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baseline, 8 weeks
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Functionality
Tidsram: baseline, 8 weeks
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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
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baseline, 8 weeks
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Sponsor
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Studieavstämningsdatum
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Studera stora datum
Studiestart
1 januari 2014
Primärt slutförande (Faktisk)
1 augusti 2015
Avslutad studie (Faktisk)
1 februari 2016
Studieregistreringsdatum
Först inskickad
26 januari 2014
Först inskickad som uppfyllde QC-kriterierna
26 januari 2014
Första postat (Uppskatta)
28 januari 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
1 november 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 oktober 2016
Senast verifierad
1 oktober 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DF0048UG
Plan för individuella deltagardata (IPD)
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OBESLUTSAM
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