Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:3/15/2019
Start Date:November 2014
End Date:October 2019
Contact:Heidi L. Pottinger, DrPH, MPH, MA
Email:heidip@email.arizona.edu
Phone:(520) 484-6600

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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.

Specific Aim #1: To compare the effectiveness of an intense physiotherapy program with the
current standard of care in the management of children with spastic cerebral palsy.

Hypothesis #1: Children receiving a short cluster of intense therapies (5 times per week for
12 weeks) will show greater functional gains as determined by the Gross Motor Function
Measure (GMFM-66) and the Pediatric Evaluation Disability Inventory (PEDI) than those
receiving the same therapies once a week, the current standard of care.

Specific Aim #2: To determine if the functional gains by children with spastic cerebral palsy
achieved with an intense physiotherapy program will continue to improve while receiving less
intense standard weekly therapies for at least 36 weeks (9 months) following completion of
the intense program.

Hypothesis #2: Motor skills gained after 12 weeks of intensely administered physiotherapies
as determined by the GMFM and the PEDI will continue to improve at a rate greater than that
seen in children receiving the same therapies once a week, the current standard of care.

Specific Aim #3: After receiving the same number of therapies at the end of the 48-week
protocol, children receiving the intense series of therapies during the first 12-weeks will
have made greater functional gains than those receiving them during the last 12-weeks.

Hypothesis #3: Children who receive intense physiotherapies at an earlier age make greater
gains then those who receive the same therapies at a later age.

Specific Aim #4: To develop a clinical profile that will identify those children most likely
to benefit from intensely administered physiotherapies.

Hypothesis #4: Clinical and radiologic characteristics play a major role in response to
therapy.

Explorative Aim: To assess the correlation between clinical improvement from intense
physiotherapies and anatomical changes using magnetic resonance imaging (MRI).

Hypothesis: The improvements from intense physiotherapies seen in the clinical assessments
will be reflected by alterations of brain connectivity parameters available from
neuroanatomical MRI and diffusion tensor imaging (DTI).

Inclusion Criteria:

1. 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).

2. Diagnosis: Diagnosis of spastic CP confirmed by a pediatric neurologist or pediatric
rehabilitation specialist.

3. 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.

4. Disease severity level: Gross Motor Function Classification System (GMFCS) levels I,
II and III.

Exclusion Criteria:

1. Diagnosis: Diagnosis of CP secondary to neuronal migration.

2. 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).

3. Co-interventions: Anticipated pharmacological intervention or procedure or
participation in other studies that may interfere with this study.
We found this trial at
4
sites
13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Principal Investigator: Ewa Brandys, MD
Phone: 407-650-7175
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Michael C. Kruer, MD
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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1802 West Parkside Lane
Phoenix, Arizona 85027
Phone: 602-682-1845
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Tucson, Arizona 85712
Principal Investigator: Burris R. Duncan, M.D.
Phone: 520-484-6600
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Tucson, AZ
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