- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07631169
The Effect of Action Observation Therapy Including Unimanual and Bimanual Activities in Chronic Stroke
Investigation of the Effects of Action Observation Therapy Including Unimanual and Bimanual Activities on Upper Extremity Functions, Activities of Daily Living, and Quality of Life in Chronic Stroke
Panoramica dello studio
Stato
Condizioni
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 hemorrhage, or subarachnoid hemorrhage. Globally, stroke remains among the leading causes of mortality and disability.
Although stroke-related mortality rates have decreased due to advancements in the medical field, the number of individuals living with motor, sensory, and cognitive impairments following a stroke is increasing. Functional insufficiency of the upper extremity is one of the most common sequelae in stroke patients, significantly restricting grasp-release functions and, consequently, activities of daily living (ADL) such as eating, drinking, dressing, and self-care. Due to these limitations, stroke survivors become dependent at various levels and face inadequacies in fulfilling their physical, emotional, and social roles, which negatively impacts their quality of life. Scientists are conducting various studies to identify effective, low-cost, and easily applicable methods that can reduce the impact of stroke and enhance recovery, thereby alleviating the substantial economic, physical, social, and psychological burden on patients and their caregivers.
Action Observation Therapy (AOT), performed by observing simple actions frequently used in ADL followed by the imitation of those observed actions, has emerged in recent years as a rehabilitation approach used to improve upper extremity functions in the treatment of stroke and various neurological diseases. The neural basis of AOT is the activation of the mirror neuron system, which is active not only during one's own movements but also when observing the movements of others. Studies using Functional Magnetic Resonance Imaging have demonstrated increased mirror neuron activity during actions performed while observing the movements of others. It is stated that observing an action and subsequently attempting to imitate it reduces interhemispheric inhibition, thereby facilitating the activation of the primary motor cortex responsible for the observed movement, easing the execution of the action, resolving motor function impairments, and enabling the relearning of functions.
Research involving ADL and stroke rehabilitation examines the effectiveness, as well as the relative advantages and disadvantages, of treatment approaches involving activities where either a single hand (unimanual) or both hands (bimanual) are used together. Interventions utilizing unimanual movements in stroke patients aim to encourage the use of the patient's paretic upper extremity, achieve improvement in the structure and functions of the affected limb, and thus increase the patient's independence in ADL. In such applications, therapeutic effects are obtained by inducing significant changes in the cortical activities of hemispheres, both contralateral and ipsilateral to the paretic upper extremity. In interventions involving bimanual movements, the patient's paretic and non-paretic upper extremities are used simultaneously during common daily activities, helping the affected extremity reach the level of the less affected limb. This benefit is thought to be related to neural coupling via healthy pathways connecting the two hemispheres of the brain. Additionally, it has been determined via magnetic resonance imaging that motor areas in the brain are more activated during bimanual movements compared to unimanual movements.
Studies conducted using AOT in stroke patients include both unimanual and bimanual activities. However, no research has been found in the literature regarding which approach yields superior benefits. Therefore, the aim of our study is to examine the effects of AOT involving exclusively unimanual and exclusively bimanual activities on upper extremity functions, ADL, and quality of life in chronic stroke patients, and to investigate whether there is a significant difference between the outcomes of these two applications.
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
Backup dei contatti dello studio
- Nome: Mustafa KAVAK, Phd
- Numero di telefono: 05065089564
- Email: mustafakavak@karabuk.edu.tr
Luoghi di studio
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Merkez
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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:
- Musa Güneş, Phd
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Sub-investigatore:
- İlker İlhanlı, Professor
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Sub-investigatore:
- Cihan Caner Aksoy, Ass. 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: Conventional Physiotherapy+Action Observation Therapy(unimanuel activities)
Participants will receive 45 minutes of general physiotherapy in addition to 30 minutes of unimanual-only activities in each session of Action Observation Therapy.
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Participants will receive 30 minutes of unimanual-only activities in each session AOT (at home via telerahabilitation) in addition to 45 minutes of conventional physiotherapy (stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic).
They will receive 3 sessions per week for 5 weeks.
Participants will receive 45 minutes of conventional physiotherapy (stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic).
They will receive 3 sessions per week for 5 weeks.
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Sperimentale: Conventional Physiotherapy+Action Observation Therapy(bimanuel activities)
Participants will receive 45 minutes of general physiotherapy in addition to 30 minutes of bimanual-only activities in each session of Action Observation Therapy.
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Participants will receive 30 minutes of bimanual-only activities in each session AOT(at home via telerahabilitation) in addition to 45 minutes of conventional physiotherapy (stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic).
They will receive 3 sessions per week for 5 weeks.
Participants will receive 45 minutes of conventional physiotherapy (stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic).
They will receive 3 sessions per week for 5 weeks.
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Altro: Conventional Physiotherapy
Participants will receive 45 minutes of conventional physiotherapy.
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Participants will receive 45 minutes of conventional physiotherapy (stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic).
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 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 test in clinical practice that evaluates upper extremity function (hand and arm) and motor performance. The test consists of 9 wooden sticks with a diameter of 9 millimeters (mm) and a standard wooden block with 9 holes with a diameter of 10 mm. The patient inserts the nine sticks one by one into the nine holes as quickly as possible 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 elapsed for the patient to insert and remove the sticks is recorded. |
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 "The Functional Independence Scale (FIS)".
Function decreases as the time spent on the test increases.
It 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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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
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Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Karabuk-03
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