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NCT Number: NCT07629024

Rehabilitation Assessment of Motor Function In Cerebral Palsy Using Explainable AI

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.

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alfarabi special education center, Islamabad, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-Based Functional Mobility and Gait Assessment

Other

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.

Primary outcomes

  1. GMFM-88

    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)

  2. 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:

    • Step length symmetry
    • Cadence
    • Stride time variability
    • Joint angle trajectories
    • Temporal asymmetry indices
  3. 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%.

  4. WeeFIM (Functional Independence Measure for Children)

    Time frame: Baseline to 6 months

    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)

Secondary outcomes

  1. System usabiity scale (SUS)

    Time frame: 6 months

    10 items likert scale questionnaire evaluating percieved usability and acceptability

Study contacts

Contact information is provided by the study sponsor or research team.

Qamar Mehmood, Phd Rehab

CONTACT

[email protected]

03335151063

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Rehabilitation Assessment of Motor Function in Ambulatory Children With Cerebral Palsy Using Explainable Machine Learning

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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