The Effect of Action Observation Therapy Including Unimanual and Bimanual Activities in Chronic Stroke

NCT07631169 | Recruiting

• 1 other identifier: Karabuk-03
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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)

• 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)

• 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)

Study Arms (3)

Conventional Physiotherapy+Action Observation Therapy(unimanuel activities)

EXPERIMENTAL

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); Other: conventional physiotherapy

Conventional Physiotherapy+Action Observation Therapy(bimanuel activities)

EXPERIMENTAL

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); Other: conventional physiotherapy

Conventional Physiotherapy

OTHER

Participants will receive 45 minutes of conventional physiotherapy.

Other: conventional physiotherapy

Interventions

conventional physiotherapy OTHER

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.

Conventional Physiotherapy; Conventional Physiotherapy+Action Observation Therapy(bimanuel activities); Conventional Physiotherapy+Action Observation Therapy(unimanuel activities)

Action Observation Therapy(unimanuel activities) OTHER

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.

Conventional Physiotherapy+Action Observation Therapy(unimanuel activities)

Action Observation Therapy(bimanuel activities) OTHER

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.

Conventional Physiotherapy+Action Observation Therapy(bimanuel activities)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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 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:

• 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.)

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Mustafa KAVAK

Karabük, Merkez, 78100, Turkey (Türkiye)

RECRUITING

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
• Research study

Central Study Contacts

Mustafa KAVAK, Phd

CONTACT

+905065089564; mustafakavak@karabuk.edu.tr

Mustafa KAVAK, Phd

CONTACT

05065089564; mustafakavak@karabuk.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There will be different researchers: the evaluator, the administrator, and the statistical analyst. Neither the evaluator nor the statistical analyst will know which group the participants belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): May 18, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)