Action Observation Therapy in Chronic Stroke

NCT06794749 | Completed

• 1 other identifier: Karabuk-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (10)

• Spasticity

  Spasticity will assessed using the Modified Ashworth Scale. As the score increases, spasticity increases. The minimum score for this scale is 1 and the maximum score is 5.

  Baseline

• Stage of hemiplegia

  "Brunnstrom Hemiplegia Recovery Staging" will be used to determine the hemiplegic stage of the patients. This scale is scored between 1 and 6. As the score increases, the patient improves.

  Baseline

• Motor function

  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.

  Baseline, five week later (after intervention), 3 months later

• Dominant side

  The "Edinburgh Hand Preference Test" will be used to determine the dominant side used by the patient in daily life.

  Baseline

• Trunk Impairment

  "Trunk Impairment Scale" will be used to evaluate trunk impairment in stroke patients. The maximum score that can be obtained from the scale is 23 points. A low score indicates poor performance, a high score indicates good performance

  Baseline

• Upper extremity function

  Evaluation of upper extremity functions (hand-arm) and motor speed will be done with the "Nine-Hole Peg Test". Function decreases as the time spent for the test increases.

  Baseline, five week later (after intervention), 3 months later

• Functional Independence

  Evaluation of upper extremity functions will be done with the "Nine-Hole Peg Test". Function decreases as the time spent on the test increases.

  Baseline, five week later (after intervention), 3 months later

• Cognitif Function

  Mini Mental Test will be used to evaluate cognitive functions. In the evaluation, 24-30 points indicate that cognitive functions are normal, 18-23 points indicate mild cognitive impairment, and 17 points and below indicate that cognitive status is severely affected.

  Baseline

• Neglect

  The Catherine Bergego Scale will be used to assess the impact of unilateral neglect after stroke on activities of daily living. 1-10 indicates mild neglect, 11-20 indicates moderate neglect, and 21-30 indicates severe neglect.

  Baseline

• Life Quality

  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.

  Baseline, five week later (after intervention), 3 months later

Study Arms (2)

Action Observation Therapy

EXPERIMENTAL

Patients received action observation therapy in addition to general physiotherapy via telerehabilitation method, 3 days a week for 5 weeks.

Other: Action Observation Therapy

Control

ACTIVE COMPARATOR

Patients received general physiotherapy in addition to face-to-face action observation treatment 3 days per week for 5 weeks.

Other: Control

Interventions

Control OTHER

Patients received general physiotherapy in addition to action observation therapy (AOT) via face-to-face telerehabilitation method for 5 weeks, 3 days a week. AOT was applied to patients as a single session per day and lasted 30 minutes. General physiotherapy session was applied face-to-face for 45 minutes.

Control

Action Observation Therapy OTHER

Patients received general physiotherapy in addition to action observation therapy (AOT) via telerehabilitation method for 5 weeks, 3 days a week. AOT was applied to patients as a single session per day and lasted 30 minutes. General physiotherapy session was applied face to face for 45 minutes.

Action Observation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Mustafa KAVAK

Karabük, Karabük Province, 78100, Turkey (Türkiye)

Location

Related Publications (2)

• 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 RESULT

• 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 RESULT

Related Links

• Research study

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mustafa KAVAK, MsC

  Karabuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, MsC

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 27, 2025
• Study Start: January 22, 2025
• Primary Completion: July 25, 2025
• Study Completion: August 5, 2025
• Last Updated: February 4, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)