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- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mustafa KAVAK, Phd
- Numéro de téléphone: +905065089564
- E-mail: mustafakavak@karabuk.edu.tr
Lieux d'étude
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Merkez
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Karabük, Merkez, Turquie (Türkiye), 78100
- Recrutement
- Karabuk University
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Contact:
- Mustafa KAVAK
- Numéro de téléphone: 05065089564
- E-mail: mustafakavak@karabuk.edu.tr
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Karabük, Merkez, Turquie (Türkiye), 78100
- Recrutement
- Mustafa KAVAK
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Sous-enquêteur:
- Elif Ulukan, PT
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Contact:
- Mustafa KAVAK, Phd
- Numéro de téléphone: +905065089564
- E-mail: mustafakavak@karabuk.edu.tr
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Sous-enquêteur:
- Cihan Caner Aksoy, Assoc. Professor
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Sous-enquêteur:
- Musa Güneş, Phd
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Sous-enquêteur:
- İlker İlhanlı, Professor
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: control
Participants will receive only conventional physiotherapy.
They will receive 3 sessions per week for 5 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Spasticité
Délai: Base de base
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La spasticité sera évaluée à l'aide de l'échelle Ashworth modifiée.
À mesure que le score augmente, la spasticité augmente.
Le score minimum pour cette échelle est de 1 et le score maximum est de 5.
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Base de base
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Stade de l'hémiplégie
Délai: Base de base
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"Brunnstrom Hemiplegia Recovery Staging" sera utilisé pour déterminer le stade hémiplégique des patients.
Cette échelle est notée entre 1 et 6.
À mesure que le score augmente, le patient s'améliore.
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Base de base
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Fonction cognitif
Délai: Base de base
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Un mini test mental sera utilisé pour évaluer les fonctions cognitives.
Dans l'évaluation, 24 à 30 points indiquent que les fonctions cognitives sont normales, 18-23 points indiquent une légère déficience cognitive et 17 points et moins indiquent que l'état cognitif est gravement affecté.
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Base de base
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Négligence
Délai: Base de base
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L'échelle de Catherine Bergego sera utilisée pour évaluer l'impact de la négligence unilatérale après un AVC sur les activités de la vie quotidienne.
1-10 indique une légère négligence, 11-20 indique une négligence modérée et 21-30 indique une grave négligence.
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Base de base
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Motor function
Délai: 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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Life Quality
Délai: 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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Dominant side
Délai: Baseline
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The "Edinburgh Hand Preference Test" will be used to determine the dominant side used by the patient in daily life.
It will be used to determine which hand the patient uses more in daily life (Score range: -100 to +100; high positive scores indicate right-handedness, high negative scores indicate left-handedness).
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Baseline
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Upper extremity function
Délai: 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".
It is a widely used clinical test that evaluates upper extremity function (hand and arm) and motor performance.
The test consists of nine wooden sticks with a diameter of 9 millimeters (mm) and a standard wooden block with nine holes of 10 mm diameter.
The patient inserts the nine sticks one by one into the nine holes as quickly as possible, placing them randomly into the holes, and then removes them one by one in the same manner.
The timer is started when the first stick is inserted and stopped when the last stick is removed and released from the hand.
The time taken for the patient to insert and remove the sticks is recorded.
A shorter time indicates better upper extremity function.
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Baseline, five week later (after intervention)
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Functional Independence
Délai: Baseline, five week later (after intervention)
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Evaluation of upper extremity functions will be done with the "Functional Independence Scale (FIS)".
The is used to assess the change and development in ADL (Applications for Daily Living) depending on the degree of disability experienced by individuals and rehabilitation programs.
Consisting of a total of 18 items, the FIS is divided into two main subcategories: motor domain (FIS-motor; 13 items) and cognitive domain (FIS-cognitive; 5 items).
All activities are rated on a 7-point scale ranging from 1 (requires full assistance during activities) to 7 (performs the activity completely independently).
The total FIS score ranges from 18 to 126 points.
A decrease in the score indicates an increase in the individual's dependence during ADL.
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Baseline, five week later (after intervention)
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Karabuk-02
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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