Cerebral palsy (CP) is a disorder of movement and posture caused by an injury to the central nervous system when the brain is most rapidly developing. The causes for the injuries to the brain are numerous and the degree of severity is large. The injuries can occur prior to birth, during the birth process, or within the first few monhs of life. Whereas the central nervous system injury is non-progressive, the motor dysfunction is often progressive. It can involve one or all four extremities but most often affects the legs, making walking difficult or impossible. The level of severity depends on the extent of the injury and can be quite mild or so severe the child is dependent on others for all his/her care. There is no known cure for CP but the brain can be reprogramed. Non-damaged neurons can be recruited to replace damaged neurons and some function can be recovered. Because of the lower myelin content and elevated concentrations of trophic factors in the young brain, releasing the capacity of neuroplasticity is greatest when the child is young. Reprograming is most likely to be accomplished with repetitive, active, task- oriented rehabilitation. The proposed double arm, randomized clinical trial will enroll 110 children ages 12 to 36 months. Group 1 will receive an intense series of physical and occupation therapies 5 times each week for 12 weeks followed by the current standard of care (SOC), the same therapies once each week for 36 weeks. Group 2 will start with the SOC for the first 36 weeks and then receive the intense series for 12 weeks. Evaluations will be done at baseline and every 12 weeks thereafter. The primary outcome measure is the change in scores on the Gross Motor Function Measure-66 (GMFM-66) from baseline to 12 weeks. Secondary outcome measures are a change in the scores on the Pediatric Evaluation Disability Inventory (PEDI) after 12 weeks, a change in the GMFM-66 and PEDI scores after 36 weeks, and after 48 weeks on the assigned therapies. Regression analysis from history, physical examination data, and MRI interpretation will be used to develop a profile of children who are most likely to benefit from the intens therapeutic approach. An exploratory aim will use diffusion tensor imagining comparing changes in neuroanatomy at 36 weeks on a subset of 20 children, 10 who had been randomized to each group. Children in this subset will be ones who were born prematurely and where there was injury to the motor neurons located in the periventricular area (periventricular leukomalacia), those neurons that are responsible for walking.

Public Health Relevance

Cerebral palsy (CP) is a chronic condition of abnormal motor function that begins shortly after birth and often worsens over time. CP adversely affects the child's development and impacts family and community. An intense series of physiotherapies administed early in life can harness the phenomenal capacity of the young brain to stimulate uninjured neurons to replace injured ones and improve function. An early and intense approach will change the current standard of care and lessen the 'burden' on families and the cost to society.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project (R01)
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Musculoskeletal Rehabilitation Sciences Study Section (MRS)
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Nitkin, Ralph M
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University of Arizona
Public Health & Prev Medicine
Schools of Public Health
United States
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