- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387887
A Vision-Based Characterization of Human Movement Scaling in Large-Amplitude Tasks
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parkinson's disease is characterized by bradykinesia and impaired motor scaling, leading to reduced movement amplitude and diminished functional performance. Large-amplitude exercise approaches are widely used to counteract these deficits by promoting exaggerated movement execution and recalibration of internal movement perception. However, during repetitive exercise sets, individuals often demonstrate a gradual reduction in movement amplitude, a phenomenon known as amplitude decay, which typically requires verbal correction by a clinician.
Despite its clinical relevance, amplitude decay has not been objectively quantified, and movement quality is commonly assessed through visual observation alone. Marker-based motion capture systems, while accurate, are impractical for routine or remote use. RGB camera-based markerless analysis offers a low-cost and accessible alternative for objective movement assessment, particularly in telerehabilitation contexts where direct visual supervision is limited.
Participants and Study Design
A total of 22-26 healthy volunteers aged 18-45 years will be recruited. All participants will be capable of independent functional movement and will provide written informed consent prior to participation. The study follows a single-session, observational design.
Exercise Protocol
Participants will perform six standardized large-amplitude exercises:
Floor-to-Ceiling Reach
Forward Step
Side Step
Sit-to-Stand
Forward Reach to Grasp and Release an Object
Big Walking
Each exercise will be recorded for eight repetitions using a single RGB camera capturing full-body movement. No wearable sensors or reflective markers will be used.
For each exercise, the first repetition will be performed without prior instruction regarding maximal effort. Immediately after completion, a clinician expert will verbally confirm whether this execution represents the participant's maximum movement amplitude. Upon confirmation, this repetition will be designated as the individual reference trial for that exercise.
Data Processing and Outcome Measures
Movement data will be analyzed using two complementary approaches:
Pose-Based Analysis:
Joint keypoints will be extracted from video using a pose estimation algorithm. Movement amplitude will be computed using joint displacement-based metrics and normalized according to individual anthropometric characteristics. Amplitude decay will be quantified by comparing early and late repetitions and by calculating repetition-wise trends.
Visual Representation Analysis:
As an exploratory component, a self-supervised vision transformer will be used to extract visual feature representations from exercise videos. Each repetition will be compared to the clinician-confirmed reference repetition using feature similarity measures. Repetition-wise similarity scores will be used to characterize within-exercise changes and identify patterns consistent with amplitude decay.
Statistical Analysis
Data distribution will be assessed for normality. Changes in movement amplitude and repetition-wise trends will be analyzed using paired statistical methods. Associations between camera-based measures and clinician observations will be explored using correlation analysis, with statistical significance set at p < 0.05.
Ethical Considerations and Expected Impact
The study involves no invasive procedures or therapeutic interventions. Video data will be anonymized and securely stored, and participants may withdraw at any time. Ethical approval has been obtained from the Biruni University Non-Interventional Ethics Committee.
This study is expected to demonstrate the feasibility of camera-based methods for objective assessment of movement amplitude and amplitude decay, providing a methodological foundation for future studies involving patient populations, automated feedback systems, and telerehabilitation applications
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Güzin Kaya Aytutuldu
- Phone Number: 05366265884
- Email: guzinkaya14@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Ability to stand, walk, reach, step, and perform sit-to-stand movements independently without assistance.
No self-reported or clinically diagnosed neurological, musculoskeletal, or vestibular disorders.
Normal or corrected-to-normal vision sufficient to follow visual instructions.
Exclusion Criteria:
- History of neurological disorders (e.g., Parkinson's disease, stroke, multiple sclerosis, traumatic brain injury).
History of major musculoskeletal injury or surgery affecting upper or lower extremities that limits movement.
Presence of balance disorders or vestibular dysfunction.
Cardiovascular, respiratory, or metabolic conditions that may limit safe participation in physical exercise.
Current pain, dizziness, or excessive fatigue during movement or exercise.
Pregnancy or any condition for which moderate-intensity physical activity is contraindicated.
Use of assistive devices for walking or balance.
Refusal or inability to provide consent for RGB video recording.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Volunteers - Observational Arm
No Intervention / Observational: All participants are healthy adult volunteers who perform standardized large-amplitude exercises while being video recorded.
No therapeutic intervention, randomization, or group allocation is applied.
All participants undergo the same exercise protocol and data collection procedures.
|
Participants perform six standardized large-amplitude exercises (Floor-to-Ceiling Reach, Forward Step, Side Step, Sit-to-Stand, Forward Reach to Grasp and Release an Object, and Big Walking).
Each exercise is repeated eight times while full-body movement is recorded using an RGB camera.
The first repetition of each exercise is clinically confirmed as the participant's maximum movement amplitude and used as a reference for subsequent observational analysis.
No therapeutic manipulation or feedback is provided beyond standard verbal confirmation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Movement Amplitude Across Repetitions
Time Frame: Baseline
|
Movement amplitude will be quantified for each repetition of six large-amplitude exercises using normalized, RGB camera-based pose estimation.
Amplitude decay will be defined as the change in movement amplitude across repeated executions within each exercise, reflecting repetition-related reduction in movement scali
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reference-Based Visual Similarity Score
Time Frame: Baseline
|
A repetition-wise visual similarity score will be computed by comparing each repetition to the clinician-confirmed maximum reference repetition using data-driven video feature representations.
Lower similarity indicates greater deviation from the maximum-amplitude execution.
|
Baseline
|
|
Repetition-Wise Amplitude Decay Trend
Time Frame: Baseline
|
Within-exercise repetition trends will be quantified using early-late repetition comparisons and slope-based measures to characterize the progression of amplitude decay across repetitions.
|
Baseline
|
|
Association Between Kinematic Amplitude and Visual Representation Measures
Time Frame: Baseline
|
Correlation between pose-based movement amplitude metrics and reference-based visual similarity scores will be evaluated to examine agreement between kinematic and visual measures of movement scaling.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
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
- Gebze Technical Uni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
RAGE BioRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Large-Amplitude Exercise Observation and Video Recording
-
Halic UniversityBiruni University; Istanbul Galata University; Fenerbahce UniversityCompleted
-
University Hospital, ToulouseNot yet recruiting
-
IRCCS San Camillo, Venezia, ItalyUniversità Politecnica delle Marche; University of GenovaUnknown
-
Texas Tech University Health Sciences CenterTerminated
-
Fenerbahce UniversityRecruitingAging | Balance Disorders | Risk of Falling in the ElderlyTurkey (Türkiye)
-
Burcin CelikOndokuz Mayıs UniversityNot yet recruitingChronic Obstructive Pulmonary Disease (COPD)
-
Centre Hospitalier Universitaire de NiceCompleted
-
Beijing Tiantan HospitalRecruitingParkinson's Disease | Multiple System Atrophy | Healthy Control | Progressive Supranuclear Palsy(PSP)China
-
Fondation Ophtalmologique Adolphe de RothschildLa Teppe InstituteCompleted
-
Centre Hospitalier Universitaire de NiceCompletedFacio-Scapulo-Humeral DystrophyFrance