Spastic hemiplegic cerebral palsy (preschool children)
Conditions
Interventions
Experimental group:Intensive Heel Weight-Bearing Stability Training
Sponsors
Children's Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Definite clinical diagnosis: Meeting the diagnostic criteria for spastic hemiplegic cerebral palsy specified in the *Chinese Guidelines for Cerebral Palsy Rehabilitation (2022 Edition)*. Subjects must provide original cranial magnetic resonance imaging (MRI) or computed tomography (CT) reports issued by Grade A tertiary hospitals to confirm definite unilateral non-progressive central nervous system injury; 2. Eligible age and disease duration: Chronological age between 3.0 and 6.0 years (inclusive) on the screening day, with a confirmed disease duration of no less than 6 months; 3. Gross motor function classification: Classified as Level ? or Level ? on the Gross Motor Function Classification System (GMFCS). Children have basic walking ability with limitations in walking speed, balance and endurance; 4. Basic motor endurance and independent walking: The child can continuously walk forward independently for at least 6 meters without lower-extremity orthoses (e.g., AFO), crutches or other walking aids; 5. Biomechanical inclusion indicators: Clinical observational gait analysis and baseline plantar pressure screening reveal typical spatial biomechanical abnormalities, including but not limited to defective heel strike on the affected side, toe-walking gait, markedly shortened single-limb support phase, or insufficient ankle dorsiflexion during the dynamic swing phase; 6. Cognition and treatment compliance: The child is fully conscious with stable vital signs. Preliminary assessment using pediatric neurodevelopmental scales and on-site interaction confirms that the child can understand and follow simple gamified motor instructions given by therapists.
Exclusion criteria
Exclusion criteria: 1. Cognitive and behavioral disorders: Patients complicated with moderate to severe intellectual developmental disorder (IDD), severe autism spectrum disorder (ASD), attention deficit hyperactivity disorder or other emotional and behavioral abnormalities, who are completely unable to follow instructions or display persistent irrational resistance during testing; 2.Severe sensory deficits: Patients with severe organic visual or hearing impairment who cannot clearly see demonstrations or hear verbal commands even after corrective measures; 3.Recent invasive interventions: Patients who have undergone any lower-extremity orthopedic surgery (e.g., tendon lengthening, selective dorsal rhizotomy [SDR]) within the previous 6 months, or received botulinum toxin type A (Botox) injections into lower-extremity core muscles (e.g., triceps surae, adductor muscle groups) within the previous 6 months; 4.Poorly controlled comorbidities: Patients with confirmed epilepsy that remains uncontrolled despite combined antiepileptic drug (AED) therapy, with clinical seizures occurring in the past 3 months;or those complicated with systemic diseases intolerant to exercise load, including severe primary cardiomyopathy, congenital heart disease, severe asthma, etc. 5. Severe secondary musculoskeletal contracture and pain: Patients with severe fixed organic joint contracture of the affected lower limb (e.g., fixed equinus contracture of the ankle with passive dorsiflexion < 0°), or recent unexplained severe limb pain and tenderness that prevents participation in high-intensity heel weight-bearing and weight-shifting training; 6.Other potential risks: Other special circumstances judged by researchers to seriously compromise data integrity or subject safety (e.g., concurrent participation in other clinical trials involving invasive or pharmaceutical interventions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-dimensional gait assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ankle joint function assessment ;Plantar pressure assessment;Gross motor function assessment;Modified Ashworth spasm scale (MAS) score;Stance Phase Percentage of Affected Side; | — |
Countries
China
Contacts
Public ContactMingdi Li
Children's Hospital of Soochow University
Outcome results
None listed