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Recruiting NCT07631182

Action Observation Therapy in Chronic Stroke Via Telerehabilitation

No phase Interventional Chronic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional physiotherapy.
Who it may be relevant to
Registry conditions: Chronic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

Stroke, a leading cause of disability worldwide, particularly affects upper extremity function, rendering individuals dependent on others for daily living activities and reducing their quality of life. To mitigate these effects, Action Observation Therapy (AOT), which has gained prominence in recent years, activates the mirror neuron system, triggering learning processes in the motor cortex and supporting functional recovery through the imitation of observed movements. Furthermore, telerehabilitation offers a significant advantage in facilitating access to rehabilitation services for these patients requiring long-term treatment, eliminating barriers such as transportation and cost. The absence of studies in the literature comparing the effectiveness of combining these two methods on hand skills and quality of life in individuals with chronic stroke with conventional physiotherapy makes investigating the clinical value of this approach academically unique and necessary.

Detailed description

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.

Interventions

  • Other Conventional physiotherapy
    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.

Primary outcome measures

  • Spasticity [Time frame: Baseline]
  • Stage of hemiplegia [Time frame: Baseline]
  • Motor function [Time frame: Baseline, five week later (after intervention)]
  • Dominant side [Time frame: Baseline]
  • Upper extremity function [Time frame: Baseline, five week later (after intervention)]
  • Functional Independence [Time frame: Baseline, five week later (after intervention)]
  • Cognitif Function [Time frame: Baseline]
  • Neglect [Time frame: Baseline]
  • Life Quality [Time frame: Baseline, five week later (after intervention)]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 2 centers
  • Karabuk University — Karabük
  • Mustafa KAVAK — Karabük

Publications

  • 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. PMID 33652680
  • 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. PMID 36160327

Identifiers

NCT: NCT07631182 · Karabuk-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗