Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
110

Summary

Conditions
Cerebral Palsy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 1236 years
Gender
Both males and females

Description

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 func...

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).

Tracking Information

NCT #
NCT02167022
Collaborators
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Tucson Medical Center
  • Phoenix Children's Hospital
  • United Cerebral Palsy-Central Arizona
  • Nemours Children's Hospital
Investigators
Principal Investigator: Burris R Duncan, MD University of Arizona