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

Functional impairments in the upper extremities following a stroke significantly restrict individuals' activities of daily living and overall quality of life; in this context, Action Observation Training (AOT) has emerged in recent years as an effective rehabilitation method that promotes motor learning processes and cortical activity by activating the mirror neuron system. Although the literature acknowledges the positive effects on neural mechanisms of both unimanuel approaches, which focus on the paretic hand alone, and bimanual approaches, which involve the simultaneous use of both hands, there remains a gap regarding which method yields superior outcomes. This study aims to compare the effectiveness of AOT interventions consisting of exclusively unimanual versus exclusively bimanual activities on upper extremity functions, activities of daily living, and quality of life in chronic stroke patients, while investigating the potential differences between the outcomes of these two distinct approaches.

Study Overview

• Status: Recruiting
• Conditions: Chronic Stroke
• Intervention / Treatment: Other: Action Observation Therapy(unimanuel activities); Other: Action Observation Therapy(bimanuel activities); Other: conventional physiotherapy

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa KAVAK, Phd; Phone Number: +905065089564; Email: mustafakavak@karabuk.edu.tr
• Study Contact Backup: Name: Mustafa KAVAK, Phd; Phone Number: 05065089564; Email: mustafakavak@karabuk.edu.tr

Study Locations

• Turkey (Türkiye)
  • Merkez
    • Karabük, Merkez, Turkey (Türkiye), 78100
      • Recruiting
      • Mustafa KAVAK
      • Sub-Investigator: Elif Ulukan, PT
      • Contact: Mustafa KAVAK, Phd; Phone Number: +905065089564; Email: mustafakavak@karabuk.edu.tr
      • Sub-Investigator: Musa Güneş, Phd
      • Sub-Investigator: İlker İlhanlı, Professor
      • Sub-Investigator: Cihan Caner Aksoy, Ass. Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Action Observation Therapy(unimanuel activities); 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.; Other: conventional physiotherapy; 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.
Experimental: 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.	Other: Action Observation Therapy(bimanuel activities); 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.; Other: conventional physiotherapy; 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.
Other: Conventional Physiotherapy; Participants will receive 45 minutes of conventional physiotherapy.	Other: conventional physiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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)
Dominant side	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).	Baseline
Upper extremity function	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)
Functional Independence	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.	Baseline, five week later (after intervention)

Collaborators and Investigators

• Sponsor: Karabuk University

Publications and helpful links

General 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.
• 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.

Helpful Links

• Research study
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Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): May 18, 2027

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Karabuk-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No