Cerebral palsy. Cerebral palsy
Conditions
Interventions
Intervention 1: Intervention group: At first, the patient's personal and demographic information will be recorded completely. The necessary questionnaires and physical examinations will be performed
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: Definitive diagnosis of cerebral palsy No seizures or with controlled seizures Parental consent
Exclusion criteria
Exclusion criteria: Severe cognitive disease Hydrocephalus Coagulation diseases Have diseases such as cancer, active infections and heart, kidney and liver diseases Evidence of a progressive neurological disease Evidence of a genetic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spasticity Assessment. Timepoint: Before injection, 3, 6 and 12 months after the intervention. Method of measurement: Physical examination and Grading of spasticity will be classified by the Modified Ashworth Scale which consist of 5 grades where 0 represents no increase in muscle tone and 5 is rigidity in flexion and extension in the affected part.;Motor and Cognitive Disability Assessment. Timepoint: Before injection, 3, 6 and 12 months after the intervention. Method of measurement: Physical examination and Functional Independence Measure (FIM) and Functional Assessment Measure (FAM) will be used to measure patient motor and cognitive disability in a wide range of conditions.;Evaluation the side effects of autologous bone marrow derived mesenchymal stem cells transplantation in cerebral palsy patients. Timepoint: 1, 3, 6 and 12 months after injection. Method of measurement: Adverse effects will be assessed based on common terminology criteria for adverse events (CTCAE, version 4.3).;Motor System Functioning. Timepoint: Before injection, 3, 6 and 12 months after the intervention. Method of measurement: Physical examination and motor function will be evaluated by the Gross Motor Function Measure (GMFM-66) and Gross Motor Function Classification System (GMFCS).;Balance Assessment. Timepoint: Before injection, 3, 6 and 12 months after the intervention. Method of measurement: Physical examination and Berg Balance Scale will be used to evaluate the balance. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeed Oraee Yazdani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed