- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07507552
Immediate Effects of PETTLEP-Based AOMI on Upper Limb Kinematics in Stroke Survivors
Immediate Effects of PETTLEP-Based AOMI on Upper Limb Kinematics in Stroke Survivors: A Randomized Controlled Trial.
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdelrahman Walid Sabee, BSc
- Phone Number: +905379600520
- Email: 2433095024@stu.istinye.edu.tr
Study Contact Backup
- Name: Begüm Kara Kaya, Asst. Prof.
- Phone Number: +90 535 572 00 21
- Email: bkara@biruni.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group: PETTLEP-based 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.
|
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).
|
|
Sham Comparator: Control Group: Cognitive and Somatic Control
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.
|
Structured operations including somatic attention (body scanning) and visuospatial control (spatial navigation) timed and paired to exhaust attention without motor system participation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately before the intervention (baseline) and immediately after the single 25-minute intervention session.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Girdle Elevation (Compensatory Strategy)
Time Frame: Immediately before and immediately after the 25-minute intervention session.
|
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.
|
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.
|
Calculated by measuring the change in the Lumbar Extension angle in the sagittal plane during the reaching phase, obtained from the OpenSim kinematic model.
|
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.
|
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.
|
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.
|
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".
|
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.
|
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).
|
Immediately before and immediately after the 25-minute intervention session.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Begüm Kara Kaya, Asst. Prof, Istinye University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/56
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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