StrokeNCT05590156
Effects of the Action Observation Therapy and Robotic Rehabilitation on the Upper-Limb Motor Function in Stroke
A study testing Conventional Rehabilitation, Robotic Rehabilitation (ExoRehab X) and Action Observation Therapy (AOT) in people with Stroke, run by Emre Şenocak at 1 site in Turkey (Türkiye).
Trial summary
This protocol will investigate the effects of action observation therapy and robotic rehabilitation on upper extremity motor functions in subacute stroke patients. Firstly, for this purpose, conventional rehabilitation approaches will take 60 minutes before both treatment methods in stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional Rehabilitation, Robotic Rehabilitation (ExoRehab X) and Action Observation Therapy (AOT)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2022to 12 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18-80 aged
- Stroke history in last six months
- Mini-Mental Status Evaluation >24 points,
- Having an Ability to sit independently,
- Presence of at least half of the range of motion of all joints for the upper extremity,
- Spasticity ≤ 2 according to the Modified Ashworth Scale,
Show all 9Show fewer
- The Fugl-Meyer Assessment for Upper Extremity score between 20-60,
- Individuals without visual impairment,
- Individuals with normal communication and cooperation skills.
Who cannot join
- Having another neurological disease,
- Having any orthopedic problems that may affect the upper extremity,
- Taking neuropsychiatric treatment,
- Individuals who had a botox history or tendon surgery,
- Using neuroleptic drugs,
- Having an ataxia,
- Individuals who attended less than 80% of the total number of sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Action Observation Therapy be an Alternative to Robotic Rehabilitation to Improve Upper Extremity Functions in Stroke Patients? A Protocol of Randomized Controlled Study
This protocol will investigate the effects of action observation therapy and robotic rehabilitation on upper extremity motor functions in subacute stroke patients. Firstly, for this purpose, conventional rehabilitation approaches will take 60 minutes before both treatment methods in stroke patients. The upper-limb conventional rehabilitation program will be applied to all patients according to their individual needs (60x3x8 minutes/day/week). This program will consist of purposeful clinical exercises with a physiotherapist.
After the conventional rehabilitation, one of the groups will receive action observation therapy, while the other will receive robotic rehabilitation. Both additional treatment methods will also be applied for 60 minutes. Treatment durations of both additional treatments are the same (60x3x8 minutes/day/week). Assessments will be made three times (Beginning, 4th week, 8th week).
Read the detailed description
Randomization: The online randomization software (www.randomizer.org) will be used for the study. After randomization, patients will be divided into two groups (AOT group, Robotic group)
Blinding: Due to the nature of the study, patient-practitioner blinding is not possible. But an independent expert will perform the statistical analysis, and single-blind will be provided.
Estimating Sample Size: Gpower 3.1.9.7 software was used for sample size calculation. To calculate the effect size, the study of Lima and Christofoletti was taken as a reference, and the effect size was calculated as 1.29. The alpha error was accepted as 5% and the power of the study was 80%. Accordingly, considering that there may be missing data in the study, it was planned to include a minimum of 30 stroke patients.
Statistical Analysis: Statistical Package for the Social Sciences (SPSS v11.5) program will be used for analysis. Whether the data is normally distributed or not will be questioned by the Shapiro-Wilks test and histogram curves. When the data are normally distributed, Independent Sample T-test will be used for comparisons between groups, and Paired-Sample T-test will be used for comparisons within groups. When the data do not show normal distribution, Mann-Whitney U Test will be used for intergroup comparisons and Wilcoxon Signed Rank Test will be used for in-group comparisons.
- Conditions
- Stroke
- Being tested
- Conventional Rehabilitation, Robotic Rehabilitation (ExoRehab X), Action Observation Therapy (AOT)
- Keywords
- Robotic Rehabilitation, Action Observation Therapy, Upper Extremity, Motor Function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RehabilitationProcedure or surgery
Conventional treatment for the upper extremity will be applied according to the patient's individual needs. A physiotherapist will apply this method in the clinic for 60 minutes. The duration of treatment is 60x3x8 minutes/day/week. Other methods will be applied in addition to the conventional treatment program.
Robotic Rehabilitation (ExoRehab X)Device
Robotic Rehabilitation
Action Observation Therapy (AOT)Procedure or surgery
Action Observation Therapy (AOT)
| Study group | Role | What they receive |
|---|---|---|
| Action Observation Therapy (AOT) | Experimental | AOT is a method based on the principle that the patient watches the movements of a healthy individual and then tries to imitate them. AOT consists of a monitoring-imitation cycle. A cycle consists of 3 minutes of observation, and 3 minutes of imitation. The intervention will consist of 10 cycles for simple functions. Complex movements will be applied by separating them into their components. The cycle time for each component is the same. Take for example, the cup-reaching function: The first component is the cup-reaching activity. The second component is the glass grip. One cycle will be completed on the first component (6 minutes), then one cycle will be completed for the second component (6 minutes) and one cycle (6 minutes) will be completed for the entire movement. Cycles will follow each other for 60 minutes.
For the AOT, 31 different videos were prepared for the shoulder, elbow, and wrist. Applications will be made in the hospital under the supervision of a physiotherapist. Receives: Procedure: Conventional Rehabilitation; Procedure: Action Observation Therapy (AOT) |
| Robotic Rehabilitation | Experimental | The robotic rehabilitation application will be performed with the ExoRehab X (HoustonBionics, Inc.) device. There is no engine to create any repulsive-pulling force in this device. It is a system that works entirely with the patient's active movement.
Active movements of the shoulder, elbow, and wrist in all directions can be performed with the device. Motion is detected with the help of the device's censor, and the avatar moves on the screen. There are 10 different purposeful games embedded in the device. The device also allows resistance exercise thanks to resistance modules.
Which joint will be trained will be determined according to the potential of the patient. For example, if programming will be done for the shoulder, elbow and wrist, the treatment time will be 20 minutes for each joint.
Applications will be made in the hospital under the supervision of a physiotherapist. Receives: Procedure: Conventional Rehabilitation; Device: Robotic Rehabilitation (ExoRehab X) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment for Upper Extremity
This form is used to detect healing in the upper extremity.
Measured: Baseline
Fugl Meyer Assessment for Upper Extremity
This form is used to detect healing in the upper extremity.
Measured: End of the 4th week
Fugl Meyer Assessment for Upper Extremity
This form is used to detect healing in the upper extremity.
Measured: End of the 8th week
Wolf Motor Function Test
This test is used for the level of motor function.
Measured: Baseline
Wolf Motor Function Test
This test is used for the level of motor function.
Measured: End of the 4th week
Wolf Motor Function Test
This test is used for the level of motor function.
Measured: End of the 8th week
Secondary outcomes (10)
Demographic Data Form
Informations about the patients
Measured: Baseline
Functional Independence questionnaire
This form helps determine an individual's level of independence.
Measured: Baseline
Functional Independence questionnaire
This form helps determine an individual's level of independence.
Measured: End of the 4th week
Functional Independence questionnaire
This form helps determine an individual's level of independence.
Measured: End of the 8th week
The Stroke-Specific Quality of Life Scale (SS-QoL)
This is a quality of life assessment scale specific to stroke patients. Individuals with a high quality of life also have a high score.
Measured: Baseline
The Stroke-Specific Quality of Life Scale (SS-QoL)
This is a quality of life assessment scale specific to stroke patients. Individuals with a high quality of life also have a high score.
Measured: End of the 4th week
The Stroke-Specific Quality of Life Scale (SS-QoL)
This is a quality of life assessment scale specific to stroke patients. Individuals with a high quality of life also have a high score.
Measured: End of the 8th week
Box and Block Test
This test is used to evaluate gross motor function of the upper extremity.
Measured: Baseline
Box and Block Test
This test is used to evaluate gross motor function of the upper extremity.
Measured: End of the 4th week
Box and Block Test
This test is used to evaluate gross motor function of the upper extremity.
Measured: End of the 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start12 Dec 2022
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
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
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emre Şenocak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Şenocak, Marmara University
- Investigators
- Emre Şenocak, MSc, Study director, Marmara UniversityAysel Yildiz Ozer, PhD, Study chair, Marmara UniversityElif Korkut, PhD, Study director, Bağcılar Education and Research HospitalAdem Aktürk, PhD, Study director, İstanbul Gelişim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590156
- Sponsor's protocol ID
- 09.2022.649
- Status last verified
- Apr 2024
- First submitted
- 17 Oct 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Senocak E, Korkut E, Akturk A, Yildiz Ozer A. Innovative upper extremity rehabilitation methods in stroke patients: a comparison of robotic rehabilitation and action observation therapy-a randomized trial. Front Neurol. 2026 Apr 16;17:1759263. doi: 10.3389/fneur.2026.1759263. eCollection 2026.
PubMed 42079819
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Action Observation Therapy be an Alternative to Robotic Rehabilitation to Improve Upper Extremity Functions in Stroke Patients? A Protocol of Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05590156
- Acronym / sponsor ID
- 09.2022.649
- Conditions
- Stroke
- Keywords
- Robotic Rehabilitation, Action Observation Therapy, Upper Extremity, Motor Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emre ŞenocakUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 21 Oct 2022 (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.
This protocol will investigate the effects of action observation therapy and robotic rehabilitation on upper extremity motor functions in subacute stroke patients. Firstly, for this purpose, conventional rehabilitation approaches will take 60 minutes before both treatment methods in stroke patients. The upper-limb conventional rehabilitation program will be applied to all patients according to their individual needs (60x3x8 minutes/day/week). This program will consist of purposeful clinical exercises with a physiotherapist.
After the conventional rehabilitation, one of the groups will receive action observation therapy, while the other will receive robotic rehabilitation. Both additional treatment methods will also be applied for 60 minutes. Treatment durations of both additional treatments are the same (60x3x8 minutes/day/week). Assessments will be made three times (Beginning, 4th week, 8th week).
Detailed description
Randomization: The online randomization software (www.randomizer.org) will be used for the study. After randomization, patients will be divided into two groups (AOT group, Robotic group)
Blinding: Due to the nature of the study, patient-practitioner blinding is not possible. But an independent expert will perform the statistical analysis, and single-blind will be provided.
Estimating Sample Size: Gpower 3.1.9.7 software was used for sample size calculation. To calculate the effect size, the study of Lima and Christofoletti was taken as a reference, and the effect size was calculated as 1.29. The alpha error was accepted as 5% and the power of the study was 80%. Accordingly, considering that there may be missing data in the study, it was planned to include a minimum of 30 stroke patients.
Statistical Analysis: Statistical Package for the Social Sciences (SPSS v11.5) program will be used for analysis. Whether the data is normally distributed or not will be questioned by the Shapiro-Wilks test and histogram curves. When the data are normally distributed, Independent Sample T-test will be used for comparisons between groups, and Paired-Sample T-test will be used for comparisons within groups. When the data do not show normal distribution, Mann-Whitney U Test will be used for intergroup comparisons and Wilcoxon Signed Rank Test will be used for in-group comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action Observation Therapy (AOT) | Experimental | Procedure: Conventional Rehabilitation, Procedure: Action Observation Therapy (AOT)AOT is a method based on the principle that the patient watches the movements of a healthy individual and then tries to imitate them. AOT consists of a monitoring-imitation cycle. A cycle consists of 3 minutes of observation, and 3 minutes of imitation. The intervention will consist of 10 cycles for simple functions. Complex movements will be applied by separating them into their components. The cycle time for each component is the same. Take for example, the cup-reaching function: The first component is the cup-reaching activity. The second component is the glass grip. One cycle will be completed on the first component (6 minutes), then one cycle will be completed for the second component (6 minutes) and one cycle (6 minutes) will be completed for the entire movement. Cycles will follow each other for 60 minutes. For the AOT, 31 different videos were prepared for the shoulder, elbow, and wrist. Applications will be made in the hospital under the supervision of a physiotherapist. |
| Robotic Rehabilitation | Experimental | Procedure: Conventional Rehabilitation, Device: Robotic Rehabilitation (ExoRehab X)The robotic rehabilitation application will be performed with the ExoRehab X (HoustonBionics, Inc.) device. There is no engine to create any repulsive-pulling force in this device. It is a system that works entirely with the patient's active movement. Active movements of the shoulder, elbow, and wrist in all directions can be performed with the device. Motion is detected with the help of the device's censor, and the avatar moves on the screen. There are 10 different purposeful games embedded in the device. The device also allows resistance exercise thanks to resistance modules. Which joint will be trained will be determined according to the potential of the patient. For example, if programming will be done for the shoulder, elbow and wrist, the treatment time will be 20 minutes for each joint. Applications will be made in the hospital under the supervision of a physiotherapist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between 18-80 aged
- Stroke history in last six months
- Mini-Mental Status Evaluation >24 points,
- Having an Ability to sit independently,
- Presence of at least half of the range of motion of all joints for the upper extremity,
Key exclusion criteria (7 listed)
- Having another neurological disease,
- Having any orthopedic problems that may affect the upper extremity,
- Taking neuropsychiatric treatment,
- Individuals who had a botox history or tendon surgery,
- Using neuroleptic drugs,
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 |
|---|---|---|
| Conventional RehabilitationConventional treatment for the upper extremity will be applied according to the patient's individual needs. A physiotherapist will apply this method in the clinic for 60 minutes. The duration of treatment is 60x3x8 minutes/day/week. Other methods will be applied in addition to the conventional treatment program. | Procedure or surgery | Action Observation Therapy (AOT), Robotic Rehabilitation |
| Robotic Rehabilitation (ExoRehab X)Robotic Rehabilitation | Device | Robotic Rehabilitation |
| Action Observation Therapy (AOT)Action Observation Therapy (AOT) | Procedure or surgery | Action Observation Therapy (AOT) |
Primary outcome
Fugl Meyer Assessment for Upper Extremity
Time frame: Baseline
This form is used to detect healing in the upper extremity.
Fugl Meyer Assessment for Upper Extremity
Time frame: End of the 4th week
This form is used to detect healing in the upper extremity.
Fugl Meyer Assessment for Upper Extremity
Time frame: End of the 8th week
This form is used to detect healing in the upper extremity.
Wolf Motor Function Test
Time frame: Baseline
This test is used for the level of motor function.
Wolf Motor Function Test
Time frame: End of the 4th week
This test is used for the level of motor function.
Wolf Motor Function Test
Time frame: End of the 8th week
This test is used for the level of motor function.
10 secondary outcomes
Demographic Data Form
Time frame: Baseline
Functional Independence questionnaire
Time frame: Baseline
Functional Independence questionnaire
Time frame: End of the 4th week
Functional Independence questionnaire
Time frame: End of the 8th week
The Stroke-Specific Quality of Life Scale (SS-QoL)
Time frame: Baseline
The Stroke-Specific Quality of Life Scale (SS-QoL)
Time frame: End of the 4th week
The Stroke-Specific Quality of Life Scale (SS-QoL)
Time frame: End of the 8th week
Box and Block Test
Time frame: Baseline
Box and Block Test
Time frame: End of the 4th week
Box and Block Test
Time frame: End of the 8th week
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 19 Apr 2024.
- Derived from this study: PubMed 42079819Senocak E, Korkut E, Akturk A, Yildiz Ozer A. Innovative upper extremity rehabilitation methods in stroke patients: a comparison of robotic rehabilitation and action observation therapy-a randomized trial. Front Neurol. 2026 Apr 16;17:1759263. doi: 10.3389/fneur.2026.1759263. eCollection 2026.
- 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.
Emre Şenocak, MSc study director
Marmara University
Aysel Yildiz Ozer, PhD study chair
Marmara University
Elif Korkut, PhD study director
Bağcılar Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Rehabilitation, Robotic Rehabilitation (ExoRehab X) and Action Observation Therapy (AOT) in people with Stroke, run by Emre Şenocak 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 9 inclusion and 7 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 19 Apr 2024. 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?
Fugl Meyer Assessment for Upper Extremity (time frame: Baseline). The study lists 6 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 NCT05590156, 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 19 Apr 2024.