Spastic Cerebral Palsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of spastic cerebral palsy according to diagnostic criteria of CP found in international guidelines; 2. Aged between 2–12 years of age;no restriction on male or female; 3. GMFCS classification levels of III, IV, or V; 4. Lower limb muscle tone in Grades I–IV in accordance to the Modified Ashworth Scale (MAS); 5. Intelligence quotient score > 35 (no worse than moderate intellectual disability) as assessed via Wechsler test scales; 6. No severe psychosocial or behavioral problems, such as high aggression or risk of self-harm; 7. No severe cardiopulmonary diseases; 8. Voluntary participation and informed consent signed.
Exclusion criteria
Exclusion criteria: 1. Initiation of oral anti-spasm medication, botulinum toxin injections, or surgery performed less than 90 days before enrollment; 2. Severe visual or auditory impairment; 3. Uncontrollable epilepsy defined as the occurrence of seizures despite the use of at least one antiepileptic drug at an adequate dose; 4. History of craniotomy or skull defects; severe neurological disorders, such as brain tumors, intracranial infection/ lesions, metal implants in the skull; 5. Severe orthopedic deformities; and immune diseases and skin infections. Drop-out criteria: 1.Subjects who voluntarily terminated treatment during the course of treatment; 2.subjects who did not receive treatment according to plan, either due to poor compliance or non-cooperation; 3.subjects who were not suitable to continue the trial due to serious adverse reactions or appearance of other accompanying diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in passive muscle stretch of left and right adductors, hamstring and gastrocnemius; | — |
Secondary
| Measure | Time frame |
|---|---|
| change in R1 (fast stretch), R2 (passive range of motion) and R2-R1 (Dynamic component of spasticity) of left and right hip adductor, knee joints and ankle joints; | — |
Countries
China
Contacts
Nanhai Maternity and Children's Hospital Affliated To Guangzhou University of Traditional Chinese Medicine