StrokeNCT06794749
Action Observation Therapy in Chronic Stroke
A study testing Action Observation Therapy in people with Stroke, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Action Observation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2025to 5 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mustafa KAVAK
Karabük, Karabük Province, 78100
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Action Observation Therapy, Control
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TherapyOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Action Observation Therapy | Experimental | Patients received action observation therapy in addition to general physiotherapy via telerehabilitation method, 3 days a week for 5 weeks. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, five week later (after intervention), 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start22 Jan 2025
- Primary completion25 Jul 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kavak, Karabuk University
- Investigators
- Mustafa KAVAK, MsC, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794749
- Sponsor's protocol ID
- Karabuk-01
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33652680Shamili 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.
PubMed 36160327
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06794749
- Acronym / sponsor ID
- Karabuk-01
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action Observation Therapy | Experimental | Other: Action Observation TherapyPatients received action observation therapy in addition to general physiotherapy via telerehabilitation method, 3 days a week for 5 weeks. |
| Control | Active comparator | Other: ControlPatients received general physiotherapy in addition to face-to-face action observation treatment 3 days per week for 5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TherapyPatients 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. | Other | Action Observation Therapy |
| ControlPatients 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. | Other | Control |
Primary outcome
Spasticity
Time frame: Baseline
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.
Stage of hemiplegia
Time frame: Baseline
"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.
Motor function
Time frame: Baseline, five week later (after intervention), 3 months later
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.
Dominant side
Time frame: Baseline
The "Edinburgh Hand Preference Test" will be used to determine the dominant side used by the patient in daily life.
Trunk Impairment
Time frame: Baseline
"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
Upper extremity function
Time frame: Baseline, five week later (after intervention), 3 months later
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.
Functional Independence
Time frame: Baseline, five week later (after intervention), 3 months later
Evaluation of upper extremity functions will be done with the "Nine-Hole Peg Test". Function decreases as the time spent on the test increases.
Cognitif Function
Time frame: Baseline
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.
Neglect
Time frame: Baseline
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.
Life Quality
Time frame: Baseline, five week later (after intervention), 3 months later
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Results publication: PubMed 33652680Mancuso 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.
- Results publication: PubMed 36160327Shamili 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.
- Research studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa KAVAK, MsC principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Therapy in people with Stroke, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06794749, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.