The Baby CHAMP Study (Children With Hemiparesis Arm and Movement Project)
Condition: Hemiparesis; Cerebral Palsy
MeSH terms: Cerebral Palsy; Paresis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The Baby CHAMP Study is a multisite clinical trial funded by the National Institutes of
      Health that is examining the the use of constraint-induced movement therapy (CIMT) for
      infants and toddlers as a effective treatment, since there have been no randomized control
      trials (RCT) for the age range as well as monitor the stress levels as related by self-report
      of parents or biological indicators. Infants and toddlers who meet study eligibility
      requirements at one of the three clinical sites (Charlottesville, VA, Columbus, OH, and
      Roanoke, VA) will be invited to enroll, and their parents will be provided all necessary
      paperwork along with informational documentation.
    

Detailed description: 
      In 2013, a systematic review of interventions for children with cerebral palsy (Novak et al,
      2013) concluded that constraint-induced movement therapy (CIMT) produces the largest
      magnitude effects of any non-surgical treatment. Similarly, the first major handbook
      summarizing the results from more than 50 studies on CIMT conducted worldwide (Ramey,
      Coker-Bolt, & DeLuca, 2013) provides additional clinical and scientific support for the
      conclusion that CIMT can produce significant benefits. There are a number of important
      unresolved issues. One concerns the need for empirical evidence that CIMT is efficacious for
      infants and toddlers, since there has been no randomized controlled trial (RCT) focused on
      this age range. Another issue under debate is whether there are different effects related to
      the type of constraint used during the therapy. The constraint is placed on the child's
      "stronger" or non-hemiparetic upper extremity while the therapy focuses on improving the
      child's skills in using the impaired or hemiparetic upper extremity. Two widely used forms of
      constraint are: 1) a full-arm cast that the child wears continuously throughout a multi-week
      period when the child receives daily therapy and 2) a part-arm splint that the child wears
      only during the time of day when he or she receives therapy. Finally, another important topic
      that has not been studied is whether CIMT is a stressful form of therapy, because it is
      high-intensity (i.e., much higher dosage than the usual and customary sessions in other forms
      of occupational and physical therapy), involves constraining the child's non-involved or less
      involved upper extremity, and takes place in the child's home and often asks parents to help
      with practice sessions during non-therapy hours. If CIMT does produce elevated stress for the
      child, the parents, or both, is this stress short-term (i.e., just at the start of therapy)
      or does this continues over the entire period of therapy? Further, does the type of
      constraint used produce different levels of stress, either at first or throughout the course
      of therapy?

      The proposed study is a randomized controlled trial (RCT) of CIMT for 72 children with
      hemiparetic spastic cerebral palsy (CP) between the ages of 6 and 24 months. The study will
      take place in two sites (Roanoke, VA and Columbus, OH), each site enrolling 36 children over
      a 3 year period. The study will address two specific aims:

      Aim 1: to test the efficacy of 3 different constraint conditions used as part of
      administering a standardized form of therapy known as ACQUIRE (DeLuca, Echols, & Ramey,
      2007). The 3 constraint conditions are: i) continuous constraint, ii) part-time constraint,
      and iii) no constraint. In all 3 groups, children will receive 3 hours of therapy per day for
      5 days per week for 4 consecutive days. Therapy is delivered by licensed occupation or
      physical therapists who have been trained to deliver ACQUIRE therapy to high fidelity. In
      addition, parents are trained to provide one hour of practice in their homes, using
      techniques compatible with those used by the ACQUIRE therapist. Efficacy will be measured
      primarily by changes in the children's assessed skill levels in using their upper
      extremities, both the hemiparetic (affected) and the non-hemiparetic (less involved) upper
      extremities, used alone and together (i.e., in completing bimanual tasks). In addition,
      changes in brain functioning related to receiving the 3 different constraint conditions will
      be measured using functional Near-Infrared Spectroscopy (fNIRS), a non-invasive and safe
      procedure that permits children to be active while recording takes place.

      Aim 2: to monitor stress levels and safety risks related to use of constraint in the 3
      conditions identified above (Aim 1). The study addresses stress levels in both the children
      and their parents, because CIMT is a high-intensity and unusual (i.e., constraining the
      child's "stronger arm") form of therapy taking place in the children's homes. Prior published
      clinical case reports indicate infants and toddlers adjust well to this form of therapy, and
      parents have favorable responses, no study previously has directly measured stress effects,
      related to self-report of parents or biological indicators, such as revealed by collecting
      saliva and hair samples to analyze for cortisol levels and changes over time.

      The study results are expected to be important to inform the field of infant rehabilitation
      and provide much-needed evidence about whether infants and toddlers show significant
      (clinically meaningful) benefits from one or more of the 3 forms of therapy being tested. The
      findings will include evidence about both behavioral and brain changes. Further, the evidence
      will answer questions about whether the immediate therapy benefits, if detected, continue to
      be measurable at 6 and 12 months after therapy has ended. In addition, the study will yield
      first-ever evidence about whether CIMT is stressful for children and their parents. It may be
      there are some children or parents who are at higher risk for showing stress effects. If so,
      the data generated by this study will be important for future clinical practice and research
      to reduce these levels. If elevated stress does not occur, or if markedly lowering of stress
      is detected, then these findings will help to resolve the uncertainty that currently prevents
      some families or clinicians from considering this form of therapy, despite the fact that
      other scientific studies have shown it produces large and lasting benefits for children age 2
      and older.
    

Intervention name(s): Neurorehabilitation therapy with cast; Neurorehabilitation therapy with splint; Neurorehabilitation bimanual
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Children in this group will have 3 hours of daily therapy each weekday for 4 weeks while wearing a full-arm cast on their stronger arm and hand. Parents will be required to do 45 minutes of daily therapy for which they will be trained.; Children in this group will have 3 hours of daily therapy each weekday for 4 weeks while wearing part-time splint on their stronger arm and hand. Parents will be required to do 45 minutes of daily therapy for which they will be trained.; Children in this group will have 3 hours of daily therapy each weekday for 4 weeks will not wear a constraint. Parents will be required to do 45 minutes of daily therapy for which they will be trained.
Other intervention name(s): Pediatric Constraint-Induced Movement Therapy; P-CIMT; Pediatric Constraint-Induced Movement Therapy; P-CIMT; Bimanual; HABIT
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: P-CIMT; Pediatric Constraint Induced Movement Therapy; Hemiparesis; Cerebral Palsy; Infants; Toddlers; Children