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Rehabilitation Assessment of Motor Function In Cerebral Palsy Using Explainable AI

5 augusti 2026 uppdaterad av: Riphah International University

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

200

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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
Övrig: AI-Based Functional Mobility and Gait Assessment
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Edinburgh visual gait scale (EVGS)
Tidsram: 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
WeeFIM (Functional Independence Measure for Children)
Tidsram: 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)
Baseline to 6 months
GMFM-88
Tidsram: 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
Tidsram: 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
Baseline to 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility of markerless video-based gait analysis for routine physiotherapy assessment in low-resource clinical settings
Tidsram: Through study completion, 12 month
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.
Through study completion, 12 month
Predictive accuracy of the machine learning model for gait and motor function
Tidsram: At model validation ,post data collection ,6 month
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.
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
Tidsram: Baseline to 6-month follow-up
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.
Baseline to 6-month follow-up

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Riphah International University

Utredare

  • Huvudutredare: Sidra Ghias, PhD* Rehab, Riphah International university Isalambad

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

30 augusti 2026

Primärt slutförande (Beräknad)

30 juni 2027

Avslutad studie (Beräknad)

30 december 2027

Studieregistreringsdatum

Först inskickad

18 maj 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

5 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • RCRAHS-ISB/REC/PhD/011111

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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