StrokeNCT06501014
Effectiveness of Action Observation Therapy in Stroke Patients
A study testing Action Observation Therapy-Experimental Group in people with Stroke and Rehabilitation, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn the effectiveness of action observation therapy in patients with stroke. The main questions it aims to answer are: Is action observation therapy an effective method in stroke patients? Researchers will compare the results of two action observation-based exercises (home… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Rehabilitation
- What is being tested?
- Action Observation Therapy-Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2024to 30 Sep 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients in the chronic phase (more than 6 months have passed since the stroke)
- Patients over 40 years of age
- Patients who can stand and walk independently (including those using walking aids)
Who cannot join
- Additional disease (neurological, orthopedic, etc.) that may affect motor performance and balance.
- Patients with communication problems
- Patients with mental problems (mini-mental test score <23)
- Patients aged 85 and over
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effectiveness of Action Observation Therapy Applied in Addition to Conventional Treatment in Stroke Patients
The goal of this clinical trial is to learn the effectiveness of action observation therapy in patients with stroke.
The main questions it aims to answer are:
Is action observation therapy an effective method in stroke patients?
Researchers will compare the results of two action observation-based exercises (home program) with conventional exercise to see whether action observation therapy works in the rehabilitation of stroke patients.
Participants:
Participants in one group will do action observation-based exercise (home plus conventional exercise for 24 sessions, Patients in the control group will only undergo conventional exercise in addition to routine treatment.
Read the detailed description
Individuals with chronic stroke will be included in this study. Participants will be randomly divided into two groups, and patients in both groups will continue their routine treatments.
Patients in the control group will only undergo conventional exercise. Patients in the study group will be given a home exercise program in addition to conventional treatment. However, patients will be asked to first watch the video of each exercise in this program and then perform the exercise.
Patients will be asked to perform the exercises 3 days a week for 8 weeks. Evaluations will be made twice, before the exercise program application begins and after the sessions are completed.
- Conditions
- Stroke, Rehabilitation
- Being tested
- Action Observation Therapy-Experimental Group, Conventional Exercises-Control Group
- 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 Therapy-Experimental GroupOther
Patients will be asked to watch the exercises before doing them.For each exercise, patients will first watch the relevant video and do the exercise after the video ends.
Conventional Exercises-Control GroupOther
Patients will be subjected to conventional exercise only.
| Study group | Role | What they receive |
|---|---|---|
| Action Observation Therapy-Experimental Group | Experimental | Patients will be asked to watch the exercises before doing them. For each exercise, patients will first watch the relevant video and do the exercise after the video ends. Receives: Other: Action Observation Therapy-Experimental Group |
| Conventional Exercises-Control Group | Active comparator | Patients will be subjected to conventional exercise only. Receives: Other: Conventional Exercises-Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 minute walk test
Patients will be asked to walk 30 meters long on a flat surface for 2 minutes. When the time is up, the distance the patient can walk will be recorded.
Measured: The evaluation will be applied at the baseline and after study completion, an average of 2 months.
Fugl-Meyer Assessment
The FMA motor assessments for the lower extremity (minimum score:0 and maximum score 34 points) will be applied. A higher score means the patient's motor movements are better.
Measured: The evaluation will be applied at the baseline and after study completion, an average of 2 months.
Berg Balance Scale
The Berg Balance Scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of funcion.
Measured: The evaluation will be applied at the baseline and after study completion, an average of 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start16 Jul 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osman Karaca, PhD, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501014
- Sponsor's protocol ID
- KaratayUO3
- Status last verified
- Oct 2025
- First submitted
- 8 Jul 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karaca O, Tekin AN. Home-based action observation training improves walking performance, balance, and lower limb motor function in chronic stroke: a randomized controlled trial. Brain Inj. 2026;40(9):802-809. doi: 10.1080/02699052.2026.2675400. Epub 2026 May 19.
PubMed 42157362
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Action Observation Therapy Applied in Addition to Conventional Treatment in Stroke Patients
- ClinicalTrials.gov ID
- NCT06501014
- Acronym / sponsor ID
- KaratayUO3
- Conditions
- Stroke, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 Jul 2024 (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.
The goal of this clinical trial is to learn the effectiveness of action observation therapy in patients with stroke.
The main questions it aims to answer are:
Is action observation therapy an effective method in stroke patients?
Researchers will compare the results of two action observation-based exercises (home program) with conventional exercise to see whether action observation therapy works in the rehabilitation of stroke patients.
Participants:
Participants in one group will do action observation-based exercise (home plus conventional exercise for 24 sessions, Patients in the control group will only undergo conventional exercise in addition to routine treatment.
Detailed description
Individuals with chronic stroke will be included in this study. Participants will be randomly divided into two groups, and patients in both groups will continue their routine treatments.
Patients in the control group will only undergo conventional exercise. Patients in the study group will be given a home exercise program in addition to conventional treatment. However, patients will be asked to first watch the video of each exercise in this program and then perform the exercise.
Patients will be asked to perform the exercises 3 days a week for 8 weeks. Evaluations will be made twice, before the exercise program application begins and after the sessions are completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action Observation Therapy-Experimental Group | Experimental | Other: Action Observation Therapy-Experimental GroupPatients will be asked to watch the exercises before doing them. For each exercise, patients will first watch the relevant video and do the exercise after the video ends. |
| Conventional Exercises-Control Group | Active comparator | Other: Conventional Exercises-Control GroupPatients will be subjected to conventional exercise only. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke patients in the chronic phase (more than 6 months have passed since the stroke)
- Patients over 40 years of age
- Patients who can stand and walk independently (including those using walking aids)
Key exclusion criteria (4 listed)
- Additional disease (neurological, orthopedic, etc.) that may affect motor performance and balance.
- Patients with communication problems
- Patients with mental problems (mini-mental test score <23)
- Patients aged 85 and over
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 Therapy-Experimental GroupPatients will be asked to watch the exercises before doing them.For each exercise, patients will first watch the relevant video and do the exercise after the video ends. | Other | Action Observation Therapy-Experimental Group |
| Conventional Exercises-Control GroupPatients will be subjected to conventional exercise only. | Other | Conventional Exercises-Control Group |
Primary outcome
2 minute walk test
Time frame: The evaluation will be applied at the baseline and after study completion, an average of 2 months.
Patients will be asked to walk 30 meters long on a flat surface for 2 minutes. When the time is up, the distance the patient can walk will be recorded.
Fugl-Meyer Assessment
Time frame: The evaluation will be applied at the baseline and after study completion, an average of 2 months.
The FMA motor assessments for the lower extremity (minimum score:0 and maximum score 34 points) will be applied. A higher score means the patient's motor movements are better.
Berg Balance Scale
Time frame: The evaluation will be applied at the baseline and after study completion, an average of 2 months.
The Berg Balance Scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of funcion.
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 10 Dec 2025.
- Derived from this study: PubMed 42157362Karaca O, Tekin AN. Home-based action observation training improves walking performance, balance, and lower limb motor function in chronic stroke: a randomized controlled trial. Brain Inj. 2026;40(9):802-809. doi: 10.1080/02699052.2026.2675400. Epub 2026 May 19.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Osman Karaca, PhD principal investigator
KTO Karatay 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-Experimental Group in people with Stroke and Rehabilitation, run by KTO Karatay 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 3 inclusion and 4 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 10 Dec 2025. 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?
2 minute walk test (time frame: The evaluation will be applied at the baseline and after study completion, an average of 2 months.). The study lists 3 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 NCT06501014, which also lists 1 linked publication.
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 10 Dec 2025.