- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mustafa KAVAK, Phd
- Numero di telefono: +905065089564
- Email: mustafakavak@karabuk.edu.tr
Luoghi di studio
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Merkez
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Karabük, Merkez, Turchia (Türkiye), 78100
- Reclutamento
- Karabuk University
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Contatto:
- Mustafa KAVAK
- Numero di telefono: 05065089564
- Email: mustafakavak@karabuk.edu.tr
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Karabük, Merkez, Turchia (Türkiye), 78100
- Reclutamento
- Mustafa KAVAK
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Sub-investigatore:
- Elif Ulukan, PT
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Contatto:
- Mustafa KAVAK, Phd
- Numero di telefono: +905065089564
- Email: mustafakavak@karabuk.edu.tr
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Sub-investigatore:
- Cihan Caner Aksoy, Assoc. Professor
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Sub-investigatore:
- Musa Güneş, Phd
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Sub-investigatore:
- İlker İlhanlı, Professor
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: control
Participants will receive only conventional physiotherapy.
They will receive 3 sessions per week for 5 weeks.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Spasticità
Lasso di tempo: Basale
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La spasticità valuterà utilizzando la scala di Ashworth modificata.
All'aumentare del punteggio, la spasticità aumenta.
Il punteggio minimo per questa scala è 1 e il punteggio massimo è 5.
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Basale
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Fase dell'emiplegia
Lasso di tempo: Basale
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La "stadiazione del recupero dell'emiplegia di Brunnstrom" verrà utilizzata per determinare lo stadio emiplegico dei pazienti.
Questa scala è valutata tra 1 e 6.
All'aumentare del punteggio, il paziente migliora.
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Basale
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Funzione cognitif
Lasso di tempo: Basale
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Mini test mentale verrà utilizzato per valutare le funzioni cognitive.
Nella valutazione, 24-30 punti indicano che le funzioni cognitive sono normali, 18-23 punti indicano una lieve compromissione cognitiva e 17 punti e sotto indicano che lo stato cognitivo è gravemente influenzato.
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Basale
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Trascurare
Lasso di tempo: Basale
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La scala di Catherine Bergego verrà utilizzata per valutare l'impatto della abbandono unilaterale dopo l'ictus sulle attività della vita quotidiana.
1-10 indica una lieve abbandono, 11-20 indica una moderata abbandono e 21-30 indica una grave abbandono.
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Basale
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Motor function
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Karabuk-02
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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