Clinical trial NCT06794749: Action Observation Therapy in Chronic Stroke
Official title: Investigation of the Effect of Action Observation Therapy Applied With Telerehabilitation Method on Upper Extremity Functions, Daily Living Activities and Quality of Life in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Functional impairment in the upper extremities is one of the most common sequelae in stroke patients. It significantly limits the patients' grasping-releasing functions and, consequently, their activities of daily living (ADL), such as eating - drinking, dressing, and self-care. Action Observation Training (AOT), performed by observing simple actions frequently used in ADL and then imitating the observed actions, reduces interhemispheric inhibition and allows the elimination of impairments in upper extremity motor function and relearning of functions in chronic stroke patients. This study aims to investigate the effects of telerehabilitation and face-to-face AOT application on upper extremity functions, activities of daily living, and quality of life in chronic stroke patients and to question whether there are differences between the short- and long-term effects of these two AOT applications.

Detailed description: Stroke is defined as a neurological picture caused by focal damage to the central nervous system due to vascular problems such as cerebral infarction or intracerebral or subarachnoid hemorrhage.

Functional impairment in the upper extremities is one of the most common sequelae in stroke patients. It significantly limits the patients' grasping-releasing functions and, consequently, their activities of daily living (ADL), such as eating - drinking, dressing, and self-care.

Action Observation Therapy (AOT), which is performed by observing simple actions frequently used in ADL and then imitating the observed actions, is a rehabilitation approach used in recent years to improve upper limb functions in the rehabilitation of stroke and various neurological diseases. It is stated that AOT reduces interhemispheric inhibition and allows the elimination of impairments in motor function and relearning of functions.

Telerehabilitation is the remote delivery of rehabilitation services through telecommunication technology. Telerehabilitation provides important advantages, such as difficulty transferring the patient to the health center, where the rehabilitation process takes a long time, travel time, and travel costs in stroke patients.

In the literature review, no study was found comparing the effect of the AOT with the telerehabilitation method and face-to-face application on the patient's upper extremity functions, activities of daily living, and quality of life in the rehabilitation of patients with chronic stroke. In addition, to our knowledge, there is no study examining the long-term effects of AOT, which has been the subject of a limited number of studies.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age,
* Diagnosis of left hemiparetic stroke,
* Having passed between 6-36 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:

* Not volunteering to participate in the study,
* Having spasticity (level 3 and 4 according to the Modified Ashworth Scale) that prevents grasping and releasing an object,
* Having contracture in any of the upper extremity joints on the affected side,
* Having a serious neglect disorder (scoring 21 and above on the Catherine Bergego Scale),
* Having cooperation, adaptation and behavioral disorders during the application of the tests used to obtain the data,
* Having mental impairment that prevents communication and receiving 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 advanced vision and hearing problems (if any, these problems have not been corrected with assistive devices such as glasses, lenses, hearing aids, etc.)

Primary outcomes:
measure: Spasticity
timeFrame: Baseline
measure: Stage of hemiplegia
timeFrame: Baseline
measure: Motor function
timeFrame: Baseline, five week later (after intervention), 3 months later
measure: Dominant side
timeFrame: Baseline
measure: Trunk Impairment
timeFrame: Baseline
measure: Upper extremity function
timeFrame: Baseline, five week later (after intervention), 3 months later
measure: Functional Independence
timeFrame: Baseline, five week later (after intervention), 3 months later
measure: Cognitif Function
timeFrame: Baseline
measure: Neglect
timeFrame: Baseline
measure: Life Quality
timeFrame: Baseline, five week later (after intervention), 3 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Mustafa KAVAK
state: Karabuk
Study officials:
affiliation: Karabuk University
name: Mustafa KAVAK, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.