- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07631182
Action Observation Therapy in Chronic Stroke Via Telerehabilitation
Investigation of the Effect of Action Observation Therapy Via Telerehabilitation Method on Upper Extremity Functions, Daily Living Activities and Quality of Life in Chronic Stroke Patients
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Stroke is defined as a neurological condition caused by focal damage to the central nervous system due to vascular problems such as cerebral infarction, intracerebral or subarachnoid hemorrhage. Stroke is among the leading causes of death and disability worldwide.
Functional impairment in the upper extremities is frequently observed in stroke patients, significantly limiting their grasping and releasing functions, and consequently their daily living activities (ADL) such as eating, drinking, dressing, and self-care. Due to these limitations, stroke patients become dependent to varying degrees, negatively impacting their quality of life. Scientists are conducting various studies to find effective, low-cost, and easily applicable methods that can reduce the effects of stroke, which imposes a significant economic, physical, social, and psychological burden on patients and their families, and improve recovery.
Action Observation Therapy (AOT), which involves observing simple actions frequently used in ADL and then imitating those observed actions, is a rehabilitation approach applied in clinical settings in recent years to improve upper extremity function in the rehabilitation of stroke and various neurological diseases. The neural basis of AOT is the mirror neuron system, which is active not only when observing one's own movements but also when observing others' movements. Studies using Functional Magnetic Resonance Imaging have shown that mirror neuron activity increases when observing the movements of others. It is stated that observing an action and then trying to imitate it reduces interhemispheric inhibition, and as a result, it activates the primary motor cortex that causes the observed movement, facilitates the execution of the action, eliminates motor function disorders, and allows for the relearning of functions.
Telerehabilitation is the remote delivery of rehabilitation services through telecommunication technology. Telerehabilitation increases the accessibility of physiotherapy interventions in situations where face-to-face rehabilitation is not possible or difficult to access. In stroke patients with a lengthy rehabilitation process, telerehabilitation offers significant advantages, including reduced difficulties in transferring the patient to the healthcare center, shorter travel time, reduced transportation costs, and lower energy costs.
A literature review revealed no studies comparing the effects of AOT delivered via telerehabilitation on upper extremity function, hand skills, daily living activities, and quality of life in patients with chronic stroke compared with conventional physiotherapy.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Mustafa KAVAK, Phd
- Telefonnummer: +905065089564
- E-Mail: mustafakavak@karabuk.edu.tr
Studienorte
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Merkez
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Karabük, Merkez, Türkei (türkiye), 78100
- Rekrutierung
- Karabuk University
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Kontakt:
- Mustafa KAVAK
- Telefonnummer: 05065089564
- E-Mail: mustafakavak@karabuk.edu.tr
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Karabük, Merkez, Türkei (türkiye), 78100
- Rekrutierung
- Mustafa KAVAK
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Unterermittler:
- Elif Ulukan, PT
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Kontakt:
- Mustafa KAVAK, Phd
- Telefonnummer: +905065089564
- E-Mail: mustafakavak@karabuk.edu.tr
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Unterermittler:
- Cihan Caner Aksoy, Assoc. Professor
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Unterermittler:
- Musa Güneş, Phd
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Unterermittler:
- İlker İlhanlı, Professor
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Being over 18 years of age,
- Diagnosis of left hemiparetic stroke,
- Having passed between 6 months since the onset of stroke,
- Being in stage 4 or 5 of the hand and stage 4, 5 or 6 of the upper extremity according to Brunnstrom staging,
- Being able to sit on a chair for 30 minutes without support (patients who scored 20 or more points in total from the Trunk Impairment Scale),
- Scoring 24 or more points from the Mini Mental Test
Exclusion Criteria:
- Unwillingness to participate in the study,
- Having spasticity that prevents grasping and releasing an object (levels 3 and 4 on the Modified Ashworth Scale),
- Having a contracture in any of the affected upper extremity joints,
- Having severe neglect disorder (scoring 21 or higher on the Catherine Bergego Scale),
- Having impaired cooperation, compliance, and behavior during the administration of tests used to obtain data,
- Having a mental impairment that prevents communication and following basic commands (scoring less than 24 on the Mini-Mental Test),
- Having additional neurological and/or orthopedic problems that may affect motor performance and sitting balance,
- Having severe visual and hearing problems (if any, these problems not corrected with assistive devices such as glasses, contact lenses, hearing aids, etc.)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Action observation Therapy
Participants will receive AOT via telerehabilitation in addition to conventional physiotherapy.
They will receive 3 sessions per week for 5 weeks.
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All participants will receive conventional physiotherapy, including stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic.
These traditional sessions will be administered by physiotherapists three times a week, each lasting 45 minutes.
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Kein Eingriff: control
Participants will receive only conventional physiotherapy.
They will receive 3 sessions per week for 5 weeks.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Spastik
Zeitfenster: Grundlinie
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Die Spastik wird mit der modifizierten Ashworth -Skala bewertet.
Mit zunehmender Bewertung nimmt die Spastik zu.
Die Mindestpunktzahl für diese Skala beträgt 1 und die maximale Punktzahl beträgt 5.
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Grundlinie
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Stadium der Hemiplegie
Zeitfenster: Grundlinie
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"Brunnstrom -Hemiplegie -Erholungstaging" wird verwendet, um das hemiplegische Stadium der Patienten zu bestimmen.
Diese Skala wird zwischen 1 und 6 bewertet.
Mit zunehmender Bewertung verbessert sich der Patient.
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Grundlinie
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Dominante Seite
Zeitfenster: Grundlinie
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Der "Edinburgh -Handpräferenztest" wird verwendet, um die dominante Seite des Patienten im täglichen Leben zu bestimmen.
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Grundlinie
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Cognitif -Funktion
Zeitfenster: Grundlinie
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Der mentale Mini -Test wird verwendet, um kognitive Funktionen zu bewerten.
Bei der Bewertung zeigen 24-30 Punkte, dass die kognitiven Funktionen normal sind, 18-23 Punkte deuten auf eine leichte kognitive Beeinträchtigung hin, und 17 Punkte und darunter deuten darauf hin, dass der kognitive Status stark beeinflusst wird.
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Grundlinie
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Vernachlässigung
Zeitfenster: Grundlinie
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Die Catherine Bergo -Skala wird verwendet, um die Auswirkungen einer einseitigen Vernachlässigung nach einem Schlaganfall auf Aktivitäten des täglichen Lebens zu bewerten.
1-10 zeigt eine leichte Vernachlässigung an, 11-20 zeigt eine mäßige Vernachlässigung an und 21-30 zeigt eine schwere Vernachlässigung auf.
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Grundlinie
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Motor function
Zeitfenster: Baseline, five week later (after intervention)
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The "Fugl-Meyer Upper Extremity Motor Assessment Scale" will be used to evaluate upper extremity motor functions.
This scale ranges from 0 to 66 points.
As the score increases, motor function improves.
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Baseline, five week later (after intervention)
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Upper extremity function
Zeitfenster: Baseline, five week later (after intervention)
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Evaluation of upper extremity functions (hand-arm) and motor speed will be done with the "Nine-Hole Peg Test".
Function decreases as the time spent for the test increases.
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Baseline, five week later (after intervention)
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Functional Independence
Zeitfenster: Baseline, five week later (after intervention)
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Evaluation of upper extremity functions will be done with the "Nine-Hole Peg Test".
Function decreases as the time spent on the test increases.
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Baseline, five week later (after intervention)
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Life Quality
Zeitfenster: Baseline, five week later (after intervention)
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The Stroke Specific Quality of Life Scale will be used to assess the quality of life of individuals with stroke.
The higher the total score, the better the quality of life of the individual with stroke.
This scale is scored between 49-245.As the score increases, the quality of life increases.
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Baseline, five week later (after intervention)
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Mancuso M, Tondo SD, Costantini E, Damora A, Sale P, Abbruzzese L. Action Observation Therapy for Upper Limb Recovery in Patients with Stroke: A Randomized Controlled Pilot Study. Brain Sci. 2021 Feb 26;11(3):290. doi: 10.3390/brainsci11030290.
- Shamili A, Hassani Mehraban A, Azad A, Raissi GR, Shati M. Effects of Meaningful Action Observation Therapy on Occupational Performance, Upper Limb Function, and Corticospinal Excitability Poststroke: A Double-Blind Randomized Control Trial. Neural Plast. 2022 Sep 16;2022:5284044. doi: 10.1155/2022/5284044. eCollection 2022.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- Karabuk-02
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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