Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

7 lipca 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

57

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Haifa, Izrael, 31021
        • Fliman Geriatric Rehabilitation Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

30 lat do 90 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Fugl-Meyer Assessment.
Ramy czasowe: 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.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Muscle Co-activation Index.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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...

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Emanuel Markovich, MD, Fliman Geriatric Rehabilitation Center
  • Dyrektor Studium: Sharon Israely, MSc., University of Haifa
  • Krzesło do nauki: Eli Carmeli, PhD., University of Hifa

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2014

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2015

Ukończenie studiów (Rzeczywisty)

1 maja 2015

Daty rejestracji na studia

Pierwszy przesłany

12 marca 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 marca 2014

Pierwszy wysłany (Oszacować)

20 marca 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

6 sierpnia 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 lipca 2015

Ostatnia weryfikacja

1 czerwca 2015

Więcej informacji

Terminy związane z tym badaniem

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj