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Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation (AssStrFunc)

7. juli 2015 opdateret af: Carmeli Eli
The purpose of this study is to evaluate by objective measures the improvement in upper extremity functioning, as reflection of motor learning, in stroke patients in the sub acute phase. The investigators hypothesize that the improvements in daily functioning are partially due to compensation strategies and partially due to motor learning.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Background: Most stroke patients continue to suffer from upper extremity motor deficiencies even after prolonged and intense rehabilitation in hospital. Even though guidelines and other studies recommend to apply a rehabilitation programs as patient reception. As opposed to that there is a scarce evidence for the efficacy of the rehabilitation.

Objectives: To evaluate by objective measures the improvement in motor performance of the upper extremity of stroke patients in the sub acute period. Secondary objective is to describe the correlation between proximal and distal motor deficiencies of the upper extremity.

Hypothesis: Patients will show better hand performance at the end of hospitalization. Part of it can be attributed to the rehabilitation and part to a spontaneous recovery. Correlation will be found for proximal and distal upper extremity motor deficiencies.

Methods:

Trial began only after the IRB research approval. All treatment sessions will implemented by the physical and occupational staff of the hospital. Assessments for the measures will be carry out by a certified physical therapist which is coinvestigator. The coinvestigator collect the raw data for analysis in Excel and than in SPSS.

20 stroke patients who meet the inclusion criteria will participate in the study, after signing an informed consent.Patients will undergo the first assessment of all measures, e.g: motor abilities by Fugl-Meyer test, handwriting kinematic and kinetic measures and surface electromyography for measurement of muscle synergy.Patients will be treated by standard rehabilitation of physical and occupational therapy for a period of 3-4 weeks. Before discharge from hospital patients will undergo another assessment of all measures, in order to evaluate the progression in their upper limb motor abilities from reception. Part of the patients will be assessed again two to three weeks after discharge as follow up.

Outcome Measures: upper limb Fugl-Meyer assessment, handwriting Air-time, pressure and velocity, EMG (i.e., muscle onset, muscle amplitude, muscle co-activation ratio).

Statistical analysis: ANOVA analysis will be used to measure time effect. Correlation between measures will be measured by Pearson's correlation. Sample size (n=20) was calculated based on 5 points improvement in Fugl-Meyer test as minimal significant change with power of 0.8 and p-level under 0.05 for significance.

Key words: Stroke, Muscle synergy, Handwriting, Fugl-Meyer

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

57

Kontakter og lokationer

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

Studiesteder

      • Haifa, Israel, 31021
        • Fliman Geriatric Rehabilitation Center

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

30 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Cohort will be selected from Fliman Rehabilitation Geriatric Center. Healthy subjects, age and gender-matched will be served as a control group.

Beskrivelse

Inclusion Criteria:

  • diagnosis of cerebral stroke with upper extremity hemiparesis
  • Ability to understand simple orders

Exclusion Criteria:

  • Other orthopedic pathology
  • Apraxia
  • Bilateral Paresis
  • Other neurologic pathology
  • sensory aphasia

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Stroke
Stroke patients at the subacute phase
task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context
Healthy controls
healthy age-matched voluntiers
no treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fugl-Meyer Assessment.
Tidsramme: T1 at the beginning of the hospital stay and folloew up at T2 one month later.
zero to 66 points scale, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.
T1 at the beginning of the hospital stay and folloew up at T2 one month later.
Muscle Onset Time.
Tidsramme: the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1
Assessed by surface electromyography device. The time period it takes the muscle to be activated and contract from a voice prompting is measured. Shorter time onset probably charcterized healthy people compared to patients after a stroke.
the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Muscle Co-activation Index.
Tidsramme: T1 at the beginning of the hospital stay and folloew up at T2 one month later.
Assessed by surface electromyography device. Indicate for the level by which muscles contract at the same time and amplitude. It will be calculated in percentage from 100%, as 100% indicate for complete co-activation between a pair of muscles.
T1 at the beginning of the hospital stay and folloew up at T2 one month later.
Handwriting Velocity
Tidsramme: T1 at the beginning of the hospital stay and follow up at T2 one month later.
Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The velocity of his writing is measured and pass from the tablet to the computer to be processed by the software.
T1 at the beginning of the hospital stay and follow up at T2 one month later.
% Maximum Voluntary Contraction.
Tidsramme: The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.
T1 at the beginning of the hospital stay and folloew up at T2 one month later.
The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.
Handwriting Pressure.
Tidsramme: T1 at the beginning of the hospital stay and folloew up at T2 one mont...
Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks, and the pressure exerted with the pen on the tablet is recorded. The data from the tablet passed to the computer to be processed by the software.
T1 at the beginning of the hospital stay and folloew up at T2 one mont...
Handwriting Off-paper Time.
Tidsramme: T1 at the beginning of the hospital stay and folloew up at T2 one mont...
Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The time the pen is on air is measured. The data from the tablet passed to the computer to be processed by the software.
T1 at the beginning of the hospital stay and folloew up at T2 one mont...

Samarbejdspartnere og efterforskere

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

Sponsor

Efterforskere

  • Ledende efterforsker: Emanuel Markovich, MD, Fliman Geriatric Rehabilitation Center
  • Studieleder: Sharon Israely, MSc., University of Haifa
  • Studiestol: Eli Carmeli, PhD., University of Hifa

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. april 2015

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

12. marts 2014

Først indsendt, der opfyldte QC-kriterier

18. marts 2014

Først opslået (Skøn)

20. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • UHai920130001

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