StrokeNCT07507552
Immediate Effects of PETTLEP-Based AOMI on Upper Limb Kinematics in Stroke Survivors
A study testing PETTLEP-based Action Observation and Motor Imagery (AOMI) in people with Stroke and Hemiplegia, run by Istinye University.
Trial summary
The purpose of this study is to investigate the immediate effects of a mental practice technique, called Physical, Environment, Task, Timing, Learning, Emotion, Perspective (PETTLEP)-based Action Observation and Motor Imagery (AOMI), on arm movement in stroke survivors. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia, Hemiplegia and/or Hemiparesis Following Stroke
- What is being tested?
- PETTLEP-based Action Observation and Motor Imagery (AOMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 20 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Female and male adults aged 40 to 80 years with a diagnosis of unilateral ischemic or hemorrhagic stroke.
- Residual voluntary movement activity of the affected upper limb.
- Mild to moderate spasticity (Modified Ashworth Scale ≤ 3).
- Adequate cognitive function to understand and follow verbal instructions (Mini-Mental State Examination ≥ 21).
- Medically stable patients, with no active or uncontrolled systemic illness.
- Ability to sit unsupported for at least 30 minutes and be able to perform brief cognitive-motor exercises.
Who cannot join
- Other central nervous system disorders (e.g., Parkinson's disease, multiple sclerosis, traumatic brain injury).
- Musculoskeletal or orthopedic conditions causing restriction of movement in the upper-limb (such as fixed contractures, severe joint deformities, shoulder subluxation).
- Severe sensory deprivation, visual neglect, or inattention that interferes with completion of the task or the ability to engage in motor imagery.
- Uncontrolled seizures, severe cardiovascular instability, or any other contraindication to imagery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immediate Effects of PETTLEP-Based AOMI on Upper Limb Kinematics in Stroke Survivors: A Randomized Controlled Trial.
The purpose of this study is to investigate the immediate effects of a mental practice technique, called Physical, Environment, Task, Timing, Learning, Emotion, Perspective (PETTLEP)-based Action Observation and Motor Imagery (AOMI), on arm movement in stroke survivors. Stroke often causes difficulty in moving the arm smoothly, leading patients to compensate by using their back or shoulder. In this study, participants will either receive a single session of the AOMI training (watching and mentally practicing a reach-to-grasp movement) or a control relaxation task. The researchers will use a smartphone-based motion capture system (OpenCap) to measure if the mental practice immediately improves the smoothness of the arm movement and reduces compensatory body movements.
Read the detailed description
This study employs a single-blind, pretest-posttest, prospective randomized controlled trial design to evaluate the acute effects of a single session of Physical, Environment, Task, Timing, Learning, Emotion, Perspective (PETTLEP)-based Action Observation and Motor Imagery (AOMI) in stroke patients. Following a stroke, patients often develop pathological movement patterns and maladaptive compensatory strategies, such as trunk displacement or shoulder girdle elevation, due to impaired motor commands. Traditional task practice requires voluntary motor output that many severely impaired patients lack. Motor imagery combined with action observation offers a cognitive simulation alternative that activates neural motor planning circuits.
A total of 28 eligible stroke survivors will be randomized in a 1:1 ratio into an experimental (AOMI) group or a control (cognitive and somatic) group. Baseline kinematics of a standardized Reach-to-Grasp task will be recorded using OpenCap, a markerless 3D motion capture system utilizing smartphone cameras.
The intervention consists of three blocks lasting approximately 25 minutes in total. The experimental group will engage in a scaffolded AOMI protocol using a 1:3 physical-to-mental practice ratio. This includes sensory priming (holding the target object), action observation (watching a 1st-person video of the task), and selective motor imagery with specific constraints targeting movement smoothness and the inhibition of compensatory trunk and shoulder movements. The control group will perform matched-duration non-motor tasks, including body scanning and visuospatial navigation.
Immediately following the intervention, the reach-to-grasp task will be re-assessed using the OpenCap system to quantify short-term changes in movement smoothness (Number of Velocity Peaks), trunk displacement, and shoulder girdle elevation.
- Being tested
- PETTLEP-based Action Observation and Motor Imagery (AOMI), Cognitive and Somatic Control Tasks
- Keywords
- Motor imagery, Action observation, Stroke, OpenCap, Kinematics, Upper limb rehabilitation
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETTLEP-based Action Observation and Motor Imagery (AOMI)Behavioural
A mental practice protocol involving sensory priming, action observation, and motor imagery of a reach-to-grasp task with selective functional constraints (Smoothness, Dissociation/Glued Back, and Relaxed Shoulder).
Cognitive and Somatic Control TasksBehavioural
Structured operations including somatic attention (body scanning) and visuospatial control (spatial navigation) timed and paired to exhaust attention without motor system participation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: PETTLEP-based AOMI | Experimental | Participants will receive a single 25-minute session of a scaffolded protocol featuring a 1:3 physical-to-mental practice ratio. The session includes sensory priming, action observation of a 1st-person video, and selective motor imagery with smoothness and trunk control constraints, followed by physical performance. Receives: Behavioral: PETTLEP-based Action Observation and Motor Imagery (AOMI) |
| Control Group: Cognitive and Somatic Control | Sham comparator | Participants will engage in a time-matched 25-minute session of non-motor tasks. This includes body scanning (paying attention to breathing and somatic sensations) and visuospatial navigation (a mental "Home Tour") to stimulate the visuospatial system without involving the motor system. Receives: Behavioral: Cognitive and Somatic Control Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Movement Smoothness (Number of Velocity Peaks)
Movement smoothness of the affected upper limb will be evaluated using the OpenCap system (a markerless 3D motion capture system). It is calculated by the Number of Velocity Peaks (NVP) derived from the hand marker (3rd Metacarpal head) velocity profile during a standardized reach-to-grasp task. A reduction in NVP indicates increased movement smoothness and better motor control.
Measured: Immediately before the intervention (baseline) and immediately after the single 25-minute intervention session.
Secondary outcomes (5)
Shoulder Girdle Elevation (Compensatory Strategy)
Calculated by measuring the relative vertical (Y axis) displacement of the Shoulder marker with respect to the Neck marker during movement using the OpenCap system.
Measured: Immediately before and immediately after the 25-minute intervention session.
Trunk Displacement (Compensatory Strategy)
Calculated by measuring the change in the Lumbar Extension angle in the sagittal plane during the reaching phase, obtained from the OpenSim kinematic model.
Measured: Immediately before and immediately after the 25-minute intervention session.
Gross Manual Dexterity - Box and Block Test (BBT)
Participants are asked to move as many blocks as they can from one side of a wooden box to the other in 60 seconds using their affected hand. The score is the number of blocks moved successfully.
Measured: Immediately before and immediately after the 25-minute intervention session.
Pain - Visual Analog Scale (VAS)
Participants indicate their pain intensity by placing a mark on a 10-cm horizontal line. The left side is labeled "no pain" (0) and the right side is labeled "worst pain imaginable".
Measured: Immediately before and immediately after the 25-minute intervention session.
Movement Imagery Ability - Movement Imagery Questionnaire-3 (MIQ-3)
Evaluates the participant's capacity for movement imagery within three subscales: Kinesthetic, Internal Visual and External Visual. Participants evaluate the vividness of imagery on a Likert scale (higher scores signify greater vividness).
Measured: Immediately before and immediately after the 25-minute intervention session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Model description
- Two-arm parallel design comparing PETTLEP-based AOMI with a cognitive and somatic control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Sabee, Istinye University
- Investigators
- Begüm Kara Kaya, Asst. Prof, Study director, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507552
- Sponsor's protocol ID
- 2026/56
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to ensure the strict privacy and confidentiality of the stroke survivors participating in this study. The data collected involves specific clinical and kinematic assessments conducted for an academic Master's thesis. The informed consent obtained from participants covers the use of their data for this specific research project and allows for publication in aggregate form only. It does not explicitly grant permission for open public data sharing. Therefore, only summary and aggregate data will be reported in the final thesis and any resulting peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of PETTLEP-Based AOMI on Upper Limb Kinematics in Stroke Survivors: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07507552
- Acronym / sponsor ID
- 2026/56
- Keywords
- Motor imagery, Action observation, Stroke, OpenCap, Kinematics, Upper limb rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 2 Apr 2026 (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 purpose of this study is to investigate the immediate effects of a mental practice technique, called Physical, Environment, Task, Timing, Learning, Emotion, Perspective (PETTLEP)-based Action Observation and Motor Imagery (AOMI), on arm movement in stroke survivors. Stroke often causes difficulty in moving the arm smoothly, leading patients to compensate by using their back or shoulder. In this study, participants will either receive a single session of the AOMI training (watching and mentally practicing a reach-to-grasp movement) or a control relaxation task. The researchers will use a smartphone-based motion capture system (OpenCap) to measure if the mental practice immediately improves the smoothness of the arm movement and reduces compensatory body movements.
Detailed description
This study employs a single-blind, pretest-posttest, prospective randomized controlled trial design to evaluate the acute effects of a single session of Physical, Environment, Task, Timing, Learning, Emotion, Perspective (PETTLEP)-based Action Observation and Motor Imagery (AOMI) in stroke patients. Following a stroke, patients often develop pathological movement patterns and maladaptive compensatory strategies, such as trunk displacement or shoulder girdle elevation, due to impaired motor commands. Traditional task practice requires voluntary motor output that many severely impaired patients lack. Motor imagery combined with action observation offers a cognitive simulation alternative that activates neural motor planning circuits.
A total of 28 eligible stroke survivors will be randomized in a 1:1 ratio into an experimental (AOMI) group or a control (cognitive and somatic) group. Baseline kinematics of a standardized Reach-to-Grasp task will be recorded using OpenCap, a markerless 3D motion capture system utilizing smartphone cameras.
The intervention consists of three blocks lasting approximately 25 minutes in total. The experimental group will engage in a scaffolded AOMI protocol using a 1:3 physical-to-mental practice ratio. This includes sensory priming (holding the target object), action observation (watching a 1st-person video of the task), and selective motor imagery with specific constraints targeting movement smoothness and the inhibition of compensatory trunk and shoulder movements. The control group will perform matched-duration non-motor tasks, including body scanning and visuospatial navigation.
Immediately following the intervention, the reach-to-grasp task will be re-assessed using the OpenCap system to quantify short-term changes in movement smoothness (Number of Velocity Peaks), trunk displacement, and shoulder girdle elevation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel design comparing PETTLEP-based AOMI with a cognitive and somatic control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: PETTLEP-based AOMI | Experimental | Behavioral: PETTLEP-based Action Observation and Motor Imagery (AOMI)Participants will receive a single 25-minute session of a scaffolded protocol featuring a 1:3 physical-to-mental practice ratio. The session includes sensory priming, action observation of a 1st-person video, and selective motor imagery with smoothness and trunk control constraints, followed by physical performance. |
| Control Group: Cognitive and Somatic Control | Sham comparator | Behavioral: Cognitive and Somatic Control TasksParticipants will engage in a time-matched 25-minute session of non-motor tasks. This includes body scanning (paying attention to breathing and somatic sensations) and visuospatial navigation (a mental "Home Tour") to stimulate the visuospatial system without involving the motor system. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female and male adults aged 40 to 80 years with a diagnosis of unilateral ischemic or hemorrhagic stroke.
- Residual voluntary movement activity of the affected upper limb.
- Mild to moderate spasticity (Modified Ashworth Scale ≤ 3).
- Adequate cognitive function to understand and follow verbal instructions (Mini-Mental State Examination ≥ 21).
- Medically stable patients, with no active or uncontrolled systemic illness.
Key exclusion criteria (4 listed)
- Other central nervous system disorders (e.g., Parkinson's disease, multiple sclerosis, traumatic brain injury).
- Musculoskeletal or orthopedic conditions causing restriction of movement in the upper-limb (such as fixed contractures, severe joint deformities, shoulder subluxation).
- Severe sensory deprivation, visual neglect, or inattention that interferes with completion of the task or the ability to engage in motor imagery.
- Uncontrolled seizures, severe cardiovascular instability, or any other contraindication to imagery.
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 |
|---|---|---|
| PETTLEP-based Action Observation and Motor Imagery (AOMI)A mental practice protocol involving sensory priming, action observation, and motor imagery of a reach-to-grasp task with selective functional constraints (Smoothness, Dissociation/Glued Back, and Relaxed Shoulder). | Behavioural | Experimental Group: PETTLEP-based AOMI |
| Cognitive and Somatic Control TasksStructured operations including somatic attention (body scanning) and visuospatial control (spatial navigation) timed and paired to exhaust attention without motor system participation. | Behavioural | Control Group: Cognitive and Somatic Control |
Primary outcome
Change in Movement Smoothness (Number of Velocity Peaks)
Time frame: Immediately before the intervention (baseline) and immediately after the single 25-minute intervention session.
Movement smoothness of the affected upper limb will be evaluated using the OpenCap system (a markerless 3D motion capture system). It is calculated by the Number of Velocity Peaks (NVP) derived from the hand marker (3rd Metacarpal head) velocity profile during a standardized reach-to-grasp task. A reduction in NVP indicates increased movement smoothness and better motor control.
5 secondary outcomes
Shoulder Girdle Elevation (Compensatory Strategy)
Time frame: Immediately before and immediately after the 25-minute intervention session.
Trunk Displacement (Compensatory Strategy)
Time frame: Immediately before and immediately after the 25-minute intervention session.
Gross Manual Dexterity - Box and Block Test (BBT)
Time frame: Immediately before and immediately after the 25-minute intervention session.
Pain - Visual Analog Scale (VAS)
Time frame: Immediately before and immediately after the 25-minute intervention session.
Movement Imagery Ability - Movement Imagery Questionnaire-3 (MIQ-3)
Time frame: Immediately before and immediately after the 25-minute intervention session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to ensure the strict privacy and confidentiality of the stroke survivors participating in this study. The data collected involves specific clinical and kinematic assessments conducted for an academic Master's thesis. The informed consent obtained from participants covers the use of their data for this specific research project and allows for publication in aggregate form only. It does not explicitly grant permission for open public data sharing. Therefore, only summary and aggregate data will be reported in the final thesis and any resulting peer-reviewed publications.
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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.
Begüm Kara Kaya, Asst. Prof study director
Istinye University
Questions about this trial
What is this clinical trial studying?
A study testing PETTLEP-based Action Observation and Motor Imagery (AOMI) in people with Stroke and Hemiplegia, run by Istinye University.
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 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: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Walid Sabee, BSc (+905379600520, 2433095024@stu.istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Movement Smoothness (Number of Velocity Peaks) (time frame: Immediately before the intervention (baseline) and immediately after the single 25-minute intervention session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.