NCT07507552

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
8mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2027

Last Updated

April 9, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 27, 2026

Last Update Submit

April 5, 2026

Conditions

Keywords

Motor imageryAction observationStrokeOpenCapKinematicsUpper limb rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately before the intervention (baseline) and immediately after the single 25-minute intervention session.

Secondary Outcomes (5)

  • Shoulder Girdle Elevation (Compensatory Strategy)

    Immediately before and immediately after the 25-minute intervention session.

  • Trunk Displacement (Compensatory Strategy)

    Immediately before and immediately after the 25-minute intervention session.

  • Gross Manual Dexterity - Box and Block Test (BBT)

    Immediately before and immediately after the 25-minute intervention session.

  • Pain - Visual Analog Scale (VAS)

    Immediately before and immediately after the 25-minute intervention session.

  • Movement Imagery Ability - Movement Imagery Questionnaire-3 (MIQ-3)

    Immediately before and immediately after the 25-minute intervention session.

Study Arms (2)

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.

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.

Behavioral: Cognitive and Somatic Control Tasks

Interventions

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).

Experimental Group: PETTLEP-based AOMI

Structured operations including somatic attention (body scanning) and visuospatial control (spatial navigation) timed and paired to exhaust attention without motor system participation.

Control Group: Cognitive and Somatic Control

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Begüm Kara Kaya, Asst. Prof

    Istinye University

    STUDY DIRECTOR

Central Study Contacts

Abdelrahman Walid Sabee, BSc

CONTACT

Begüm Kara Kaya, Asst. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single-blind study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm parallel design comparing PETTLEP-based AOMI with a cognitive and somatic control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist and Master's Student

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

March 20, 2027

Last Updated

April 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.