Cerebral Palsy ChildrenNCT07629024
Rehabilitation Assessment of Motor Function In Cerebral Palsy Using Explainable AI
An observational study of Cerebral Palsy Children, run by Riphah International University at 4 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy Children
- What is being tested?
- AI-Based Functional Mobility and Gait Assessment
- How many people
- 200 participants
- Where
- 4 sitesPakistan
- Study dates
- 30 Aug 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Recent orthopedic or neurosurgical interventions (<6 months).
- Uncontrolled seizures affecting gait.
- Non-ambulatory (GMFCS IV-V) or cognitive impairments preventing cooperation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan4 sites
Alfarabi special education center
Islamabad
Sidra Ghias, PhD*, 03224356227, sidrahasan1989@gmail.com
sidrahasan1989@gmail.com
Army special education Academy
Islamabad
National institute of Rehabilitation medicine
Islamabad
Sidra Ghias, PhD*, 03224356227, sidrahasan1989@gmail.com
sidrahasan1989@gmail.com
Karachi institue of neurological diseases and rehabilitation(KIND-R)
Karachi
Sidra Ghias, PhD*, 03314140498, sidrahasan1989@gmail.com
sidrahasan1989@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy Children
- Being tested
- AI-Based Functional Mobility and Gait Assessment
- Keywords
- CP Assesment, Explainable machine learning, Gait symmetry, Functional independence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: AI-Based Functional Mobility and Gait Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to 6 months followup
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
Measured: 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%.
Measured: 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)
Measured: Baseline to 6 months
Secondary outcomes (3)
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.
Measured: Through study completion, 12 month
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.
Measured: At model validation ,post data collection ,6 month
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.
Measured: Baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy ChildrenStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Ghias, PhD* Rehab, Principal investigator, Riphah International university Isalambad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629024
- Sponsor's protocol ID
- RCRAHS-ISB/REC/PhD/011111
- Status last verified
- Aug 2026
- First submitted
- 18 May 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Assessment of Motor Function in Ambulatory Children With Cerebral Palsy Using Explainable Machine Learning
- ClinicalTrials.gov ID
- NCT07629024
- Acronym / sponsor ID
- RCRAHS-ISB/REC/PhD/011111
- Conditions
- Cerebral Palsy Children
- Keywords
- CP Assesment, Explainable machine learning, Gait symmetry, Functional independence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Children with Spastic Cerebral Palsy (GMFCS I-III) | – | Other: AI-Based Functional Mobility and Gait AssessmentChildren 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 |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Recent orthopedic or neurosurgical interventions (<6 months).
- Uncontrolled seizures affecting gait.
- Non-ambulatory (GMFCS IV-V) or cognitive impairments preventing cooperation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Based Functional Mobility and Gait AssessmentParticipants 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. | Other | Ambulatory Children with Spastic Cerebral Palsy (GMFCS I-III) |
Primary outcome
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)
Markerless Gait Analysis
Time frame: Baseline to 6 months
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
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%.
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)
3 secondary outcomes
Feasibility of markerless video-based gait analysis for routine physiotherapy assessment in low-resource clinical settings
Time frame: Through study completion, 12 month
Predictive accuracy of the machine learning model for gait and motor function
Time frame: At model validation ,post data collection ,6 month
Robustness of model predictive performance and change in functional and gait outcomes across heterogeneous therapy exposure contexts
Time frame: Baseline to 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sidra Ghias, PhD* Rehab principal investigator
Riphah International university Isalambad
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy Children, run by Riphah International University at 4 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qamar Mehmood, Phd Rehab (03335151063, qamar.mehmood@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMFM-88 (time frame: Baseline to 6 months followup). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.