NCT07629024

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jun 2026

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

May 18, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 10, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

May 18, 2026

Last Update Submit

June 23, 2026

Conditions

Cerebral Palsy Children

Keywords

CP AssesmentExplainable machine learningGait symmetryFunctional independence

Outcome Measures

Primary Outcomes (4)

  • 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)

    Baseline to 6 months followup

  • Markerless Gait Analysis

    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

    Baseline to 6 months

  • 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%.

    Baseline to 6 Months

  • 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)

    Baseline to 6 months

Secondary Outcomes (1)

  • System usabiity scale (SUS)

    6 months

Study Arms (1)

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

Other: AI-Based Functional Mobility and Gait Assessment

Interventions

AI-Based Functional Mobility and Gait AssessmentOTHER

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.

Ambulatory Children with Spastic Cerebral Palsy (GMFCS I-III)

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • Recent orthopedic or neurosurgical interventions (\<6 months).
  • Uncontrolled seizures affecting gait.
  • Non-ambulatory (GMFCS IV-V) or cognitive impairments preventing cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alfarabi special education center

Islamabad, Pakistan

Location

Army special education Academy

Islamabad, Pakistan

Location

National institute of Rehabilitation medicine

Islamabad, Pakistan

Location

Karachi institue of neurological diseases and rehabilitation(KIND-R)

Karachi, Pakistan

Location

Study Officials

  • Sidra Ghias, PhD* Rehab

    Riphah International university Isalambad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qamar Mehmood, Phd Rehab

CONTACT

03335151063qamar.mehmood@riphah.edu.pk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

June 5, 2026

Study Start

June 10, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(4)