Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation (AssStrFunc)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
-
Haifa, Israel, 31021
- Fliman Geriatric Rehabilitation Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Fugl-Meyer Assessment.
Zeitfenster: 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.
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Muscle Co-activation Index.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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...
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Emanuel Markovich, MD, Fliman Geriatric Rehabilitation Center
- Studienleiter: Sharon Israely, MSc., University of Haifa
- Studienstuhl: Eli Carmeli, PhD., University of Hifa
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UHai920130001
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .