Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy

Completed · Not applicable

Conditions studied: Cerebral Palsy

In brief

Cerebral palsy (CP) is a non-progressive disorder caused by an insult or injury to the brain when the brain is most rapidly developing and which results in some motor dysfunction. Causes for the injury to the brain are numerous and can occur prior to birth, during the birth process, or within the first few months following birth. The motor dysfunction can involve any or all four extremities but most often affects the legs, causing abnormal ambulation. The level of severity depends on the extent of the injury to the brain and can be mild to severe. In severe instances, the child is dependent on others for all his/her care. There is no known cure for CP, but physical and occupational therapies are administered in an attempt to improve function. The frequency of these therapies varies from once a week (the standard of care in the Western Hemisphere) to five times a week (the standard of care in Asia and some Eastern European countries). The current understanding of brain plasticity offers a theoretical explanation to justify the more intense approach. Active repetitive motor skill-directed rehabilitation utilizes the plasticity of the brain and can restore some function. Intense active physiotherapy can stimulate non-injured but 'dormant' neurons and prevent their 'natural' degeneration in order for them to substitute for the function of injured neurons. It is the very young brain that is most likely to respond to this therapy. The aim of this proposal is to evaluate the effect of administering both physical and occupational therapy five times each week for 12 weeks and compare it with the standard of care (SOC) approach of one time each week in children between the ages of 12 months and 36 months. This is the first randomized crossover trial to both enroll this young a population of children with cerebral palsy as well as to evaluate this approach from both the therapists and the parents perspectives. The number of children that this study will enroll is larger than in most CP studies. The children will be evaluated clinically with two validated instruments, one of which was designed specifically for children with CP and is administered and scored by certified therapists and the other which was designed for children with developmental disabilities and is scored by the child's care provider. A sub-set of children will have a special type of MRI to evaluate any changes in the neurological structure of the brain. The Department of Pediatrics at the University of Arizona recently completed a collaborative study with the Neurologic Department at the Beijing Children's Hospital where the intense approach of five therapies per week is the SOC. The positive results prompted another investigation to determine if such an approach would be feasible in the United States. A compliance rate of 81% confirmed feasibility and the perception that parents who have a child diagnosed with CP will do whatever they can to improve their child's motor function.

Key facts

Study ID

NCT02167022

Run by

University of Arizona

People needed

90

Starts

2014-09-30

Expected to finish

2021-07-31

Last updated by the study team

2022-01-04

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 12 to 36 months of age (The diagnosis of CP is often uncertain under the age of 12 months. The cutoff at 36 months is to have a population of young children when the brain is most "plastic" and most susceptible to reorganization).
• Diagnosis: Diagnosis of spastic CP confirmed by a pediatric neurologist or pediatric rehabilitation specialist.
• Etiology: The insult to the central nervous system that caused the motor dysfunction must have occurred during gestation or within one year after birth independent of gestational age.
• Disease severity level: Gross Motor Function Classification System (GMFCS) levels I, II and III.

You may not qualify if…

• Diagnosis: Diagnosis of CP secondary to neuronal migration.
• Co-morbidities: Medical conditions that may prevent the administration of rehabilitation therapies at the intensity required by the study, or that may compromise the study ability to maintain blindness, or that have a co-morbidity not typically associated with CP (i.e. cancer, cystic fibrosis).
• Co-interventions: Anticipated pharmacological intervention or procedure or participation in other studies that may interfere with this study.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• United Cerebral Palsy-Central Arizona — Phoenix, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• Nemours Children's Hospital — Orlando, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.