ankle-foot motor dysfunction in children with cerebral palsy
Conditions
Interventions
control group:rehabilitation training and RA101S
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: (1) Age: 3-12 years old; Gender: Unlimited; (2) Height: 80cm-160cm; (3) Spastic cerebral palsy in clinical diagnosis; (4) Ankle-foot motor dysfunction with active dorsiflexion angle > 95 degrees; (5) GMFCS level I-III; (6) Expected to adhere to treatment for 8 weeks and above; (7) The subject's guardian understands the purpose of the trial, shows sufficient adherence to the trial protocol, and signs an informed consent form (ICF); If the subject is above 8-year-old, he should also agree and sign an ICF.
Exclusion criteria
Exclusion criteria: (1) Existence of severe bone tumors, bone and joint diseases, or unstable fractures; (2) There is severe contracture of the lower limbs or other neuromuscular diseases; (3) Existence of severe cognitive, language or sensory impairments; (4) Cannot cooperate with treatment due to severe mental retardation; (5) Unstable condition in 3 months before enrollment; (6) The presence of severe lower limb skin or vascular disease; (7) Existence of severe cardio-cerebral vascular disease, acute systemic disease, severe infectious disease, bleeding tendency, mental illness; (8) Seizures that cannot be controlled by the drug in 12 months before enrollment; (9) Received major surgery in 6 months before enrollment; (10) Botulinum toxin A (BTX-A) injection into the lower limbs in 6 months before enrollment; (11) Participated in other drugs or medical device clinical trials in 3 months before enrollment; (12) The investigator thinks that the subject is not appropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall efficacy; | — |
Countries
China
Contacts
Public ContactLyu Zhongli
Beijing Children's Hospital, Capital Medical University
Outcome results
None listed