Rehabilitation Assessment of Motor Function In Cerebral Palsy Using Explainable AI

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-18
SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Recent orthopedic or neurosurgical interventions (<6 months).

Uncontrolled seizures affecting gait.

Non-ambulatory (GMFCS IV-V) or cognitive impairments preventing cooperation.

Trial population

Children with cerebral palsy classified within Gross Motor Function Classification System (GMFCS) Levels I-III who are ambulatory with or without assistive devices and receiving routine physiotherapy rehabilitation. Participants from all cerebral palsy subtypes will be included for clinical, functional, and gait assessment related to AI-based evaluation of functional mobility and gait outcomes.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • AI-Based Functional Mobility and Gait Assessment

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Ambulatory Children with Spastic Cerebral Palsy (GMFCS I-III)1 intervention

Trial outcomes

Primary outcomes

1

GMFM-88

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)

Time frame
Baseline to 6 months followup
2

Markerless Gait Analysis

Gait videos will be processed using a validated markerless pose estimation framework . Spatiotemporal and kinematic gait parameters will be extracted, including but not limited to: * Step length symmetry * Cadence * Stride time variability * Joint angle trajectories * Temporal asymmetry indices

Time frame
Baseline to 6 months
3

Edinburgh visual gait scale (EVGS)

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%.

Time frame
Baseline to 6 Months
4

WeeFIM (Functional Independence Measure for Children)

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)

Time frame
Baseline to 6 months

Secondary outcomes

1

Feasibility of markerless video-based gait analysis for routine physiotherapy assessment in low-resource clinical settings

Feasibility will be evaluated using: (1) video acquisition success rate; (2) data processing completion rate; (3) time required for analysis; and (4) clinician usability and interpretability feedback, obtained through structured questionnaires and semi-structured interviews with practicing physiotherapists regarding SHAP-based model outputs.

Time frame
Through study completion, 12 month
2

Predictive accuracy of the machine learning model for gait and motor function

Model performance will be evaluated using RMSE, MAE, and R² for continuous outcomes. Explainability will be assessed using SHAP values, with examination of feature importance consistency across cross-validation folds. based on gait and motor function data collected from participants with ambulatory cerebral palsy.

Time frame
At model validation ,post data collection ,6 month
3

Robustness of model predictive performance and change in functional and gait outcomes across heterogeneous therapy exposure contexts

The Phase 2 trained model will be applied to 6-month follow-up data without retraining. Predictive performance (RMSE, MAE, R²) will be compared across therapy exposure subgroups (regular vs. irregular/no physiotherapy). Temporal prognosis will additionally be characterized using change from baseline in GMFM-66, WeeFIM, and EVGS, alongside gait symmetry indices derived from video analysis.

Time frame
Baseline to 6-month follow-up

Other outcomes

Sponsors and contacts

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