Spastic diplegia
Conditions
Interventions
Sponsors
The Third Affiliated Hospital of Jiamusi University/ The First Affiliated Hospital of Anhui Medical University/ Xi'an TCM Hospital of Encephalopathy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Child aged 12 to 36 months; 2. Child with cerebral palsy and clinical classification of spastic diplegia, gross motor function grading system (GMFGS) I-III; 3. Willing to follow the protocol, and the guardian of the subject voluntarily signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with serious visual, auditory or intellectual disorders; 2. Patients with other diseases that affect motor function, or with other diseases; 3. Patients with severe other organ dysfunction; 4. Patients who are allergic to the study drug and its excipients; 5. Patients who received oral administration, intramuscular injection, intrathecal injection of drugs to reduce muscle tension or surgical treatment 180 days before the start of the study or during the follow-up period; 6. Patients who received the same NGF or other neuroprotective agents, traditional Chinese medicine or health food for less than 14 days; 7. Subjects who have participated in clinical trials of other new drugs in the last 90 days; 8. Other subjects who are not suitable to participate in this study according to the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gross Motor Function Measure 88 items; | — |
Secondary
| Measure | Time frame |
|---|---|
| Children's Functional Independence Rating Scale (WeeFIM);Gait analysis;Head MRI; | — |
Countries
China
Contacts
Public ContactXiaojie Li/Jiulai Tang/ Wei Pang/ Hujie Song
The Third Affiliated Hospital of Jiamusi University
Outcome results
None listed