- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07629024
Rehabilitation Assessment of Motor Function In Cerebral Palsy Using Explainable AI
Rehabilitation Assessment of Motor Function in Ambulatory Children With Cerebral Palsy Using Explainable Machine Learning
The goal of this observational study is to develop and validate an AI-based prediction model for functional mobility and gait outcomes in children with cerebral palsy using low-cost clinical and gait data collected in rehabilitation settings in Pakistan. The study aims to determine whether machine learning models can accurately predict mobility status, gait symmetry, and functional independence in ambulatory and non-ambulatory children with cerebral palsy.
The main questions it aims to answer are:
- Can clinical and gait-related variables accurately predict functional mobility and gait outcomes in children with spastic cerebral palsy?
- Can video-based assessment tools provide clinically useful data for AI-based rehabilitation assessment in low-resource settings?
Researchers will analyze clinical, functional, and gait data to identify patterns associated with mobility limitations and rehabilitation outcomes.
Participants will:
- Undergo clinical and functional assessments, including measures of balance, mobility, posture, and functional independence.
- Perform gait and movement tasks while data are collected using AI-based video analysis tools.
- Participate in routine rehabilitation sessions while their movement and functional performance are recorded for analysis.
- Provide demographic and clinical information relevant to cerebral palsy severity and functional status.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children with cerebral palsy (CP) commonly experience limitations in functional independence and mobility, which significantly affect participation and quality of life. Accurate assessment of these functional abilities is essential for rehabilitation planning, prognosis estimation, and monitoring treatment outcomes. However, conventional assessment methods largely depend on therapist observation and standardized clinical scales, which may be subjective, time-consuming, and less sensitive to complex interactions among clinical variables. In low-resource rehabilitation settings, the limited availability of advanced assessment technologies further restricts objective and data-driven clinical decision-making. Therefore, there is a growing need for innovative, accessible, and reliable approaches to improve rehabilitation assessment in children with CP.
The novelty of this study lies in the application of machine learning techniques to rehabilitation assessment of functional independence and mobility in children with cerebral palsy. Unlike traditional approaches that rely solely on isolated clinical interpretation, this study aims to integrate multiple clinical and functional parameters to identify predictive patterns associated with mobility and independence outcomes. The proposed approach introduces a data-driven and potentially more objective framework for rehabilitation assessment, supporting early identification of functional limitations and personalized intervention planning. Additionally, conducting this research in a low-resource context contributes further novelty by exploring the feasibility of implementing machine learning-based rehabilitation assessment tools in settings where advanced gait laboratories and expensive technologies are not readily available.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Qamar Mehmood, Phd Rehab
- Phone Number: 03335151063
- Email: qamar.mehmood@riphah.edu.pk
Study Locations
-
-
-
Islamabad, Pakistan
- Alfarabi special education center
-
Contact:
- Sidra Ghias, PhD*
- Phone Number: 03224356227
- Email: sidrahasan1989@gmail.com
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Contact:
- Email: sidrahasan1989@gmail.com
-
Principal Investigator:
- Sidra Ghias, PhD*
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Islamabad, Pakistan
- Army special education Academy
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Islamabad, Pakistan
- National institute of Rehabilitation medicine
-
Contact:
- Sidra Ghias, PhD*
- Phone Number: 03224356227
- Email: sidrahasan1989@gmail.com
-
Contact:
- Email: sidrahasan1989@gmail.com
-
Principal Investigator:
- Sidra Ghias, PhD*
-
Karachi, Pakistan
- Karachi institue of neurological diseases and rehabilitation(KIND-R)
-
Contact:
- Email: sidrahasan1989@gmail.com
-
Principal Investigator:
- Sidra Ghias, PhD*
-
Contact:
- Sidra Ghias, PhD*
- Phone Number: 03314140498
- Email: sidrahasan1989@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 4 to18 years
- Diagnosed any motor type of cerebral palsy (spastic, dyskinetic, ataxic, mixed),)
- GMFCS levels I -III (able to walk with or without an assistive device).
- All participants must be able to ambulate at least 10 meters with or without an assistive device.
- Capable of following simple verbal instructions.
- Parental informed consent and child assent
Exclusion Criteria:
- Recent orthopedic or neurosurgical interventions (<6 months).
- Uncontrolled seizures affecting gait.
- Non-ambulatory (GMFCS IV-V) or cognitive impairments preventing cooperation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Ambulatory Children with Spastic Cerebral Palsy (GMFCS I-III)
Children diagnosed with spastic cerebral palsy who are ambulatory and classified within Gross Motor Function Classification System (GMFCS) Levels I to III.
Participants will undergo clinical, functional, and gait assessments for AI-based prediction of functional mobility and gait outcomes
|
Participants will continue receiving their standard/routine physiotherapy rehabilitation program as prescribed by their treating therapist.
The study will involve observational collection of clinical, functional, and gait-related data using standardized assessment tools, and AI-based video analysis.
No additional therapeutic intervention will be administered specifically for research purposes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GMFM-66
Time Frame: Baseline to 6 months followup
|
GMFM (Gross Motor Function Measure) Reliability: Excellent.
Internal consistency Cronbach's α ~0.997-1.00;
intra- and inter-rater ICC ~0.994-0.999
(both GMFM-88 & GMFM-66) Validity: Construct and concurrent validity supported by strong correlations with related motor function classifications (e.g., GMFCS, PEDI mobility)
|
Baseline to 6 months followup
|
|
Markerless Gait Analysis
Time Frame: Baseline to 6 months
|
Gait videos will be processed using a validated markerless pose estimation framework (MediaPipe) Spatiotemporal and kinematic gait parameters will be extracted, including but not limited to:
|
Baseline to 6 months
|
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Edinburgh visual gait scale (EVGS)
Time Frame: Baseline to 6 Months
|
Edinburgh visual gait scale (EVGS) EVGS can be a supportive tool that adds quantitative data instead of only qualitative assessment to a video only gait evaluation.
Interobserver agreement is 60-90% and Kappa values are 0.18-0.85
for the 17 items in EVGS.
Reliability is higher for distal segments (foot/ankle/knee 63-90%; trunk/pelvis/hip 60-76%).
Agreement between EVGS and 3DGA is 52-73%.
|
Baseline to 6 Months
|
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WeeFIM (Functional Independence Measure for Children)
Time Frame: Baseline to 6 months
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WeeFIM (Functional Independence Measure for Children) Reliability: High internal consistency and ICCs (motor and cognitive scales) ~0.91-0.98 in children with cerebral palsy Validity: Construct and external validity supported (scale fits Rasch model expectations and correlates with related developmental measures)
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System usabiity scale (SUS)
Time Frame: 6 months
|
10 items likert scale questionnaire evaluating percieved usability and acceptability
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sidra Ghias, PhD* Rehab, Riphah International university Isalambad
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
Other Study ID Numbers
- RCRAHS-ISB/REC/PhD/011111
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.
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