Feasibility of Pediatric CIMT by Televideo
Condition: Hemiplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The study will test a remotely delivered, intensive, therapist-led, pediatric CIMT
      intervention, to improve the quality and frequency of upper limb movement during functional
      activity. We will evaluate: remote assessment of patient motor outcomes; computer-based video
      interaction for parent training in shaping therapeutic activities; child, parent, and
      therapist interactions; remote delivery of treatment; and the usability and usefulness of
      technology (e.g. reliability of internet connection; video streaming). As a final product,
      the study will yield a feasible and acceptable tele-rehabilitation protocol that meets our
      fidelity and reliability criteria and is ready for larger-scale efficacy testing in children
      with hemiplegic CP, ages 1-10 years.
    

Detailed description: 
      Cerebral palsy (CP) is a public health problem that affects 2-3 per 1000 children. Up to 75 %
      of children with cerebral palsy will have motor impairments that can lead to lifelong
      disability, therefore there is a need for effective treatment of these motor impairments. A
      body of evidence shows that intensive motor therapies can improve arm and hand (upper limb)
      motor function in children with CP. Constraint induced movement therapy (CIMT) is one of the
      motor therapies with the strongest evidence base for its effectiveness. Our team has
      developed an innovative CIMT protocol to treat upper limb impairments due to CP. This
      protocol combines 1) high dosage of motor treatments, (up to 3-6 hours of therapy per day for
      20 days); 2) constraint of the unaffected arm, 3) the incorporation of behavior motivation
      techniques to encourage the child to perform increasingly complex motor tasks; 4) treatment
      within the home to promote generalization of the motor behaviors; and 5) a post-therapy
      treatment plan for the parents to continue after the formal CIMT protocol is done. In a
      recent randomized controlled trial, we tested the effect of this CIMT protocol on upper limb
      function in children with hemiplegic CP. Children who received CIMT at the 30-hour and
      60-hour doses had significantly better function immediately post-treatment than children who
      received usual and customary care. This difference persisted at 6 months after treatment for
      the children who received the 60-hour dose. These results provide clear evidence that the
      higher therapy dose resulted in greater sustained improvement of upper limb function.

      Through our work in this and other clinical trials, we recognized that our treatment protocol
      delivered in the home cannot be delivered to children who live in rural areas beyond the
      reach of our therapists or in urban communities whose families are unable to have therapists
      work in their homes for 20 days. This limitation disproportionately affects families who live
      in medically resource poor areas. To address this barrier to access, we propose to modify our
      CIMT protocol so it can be used for telehealth delivery. Rehabilitation by telehealth has
      drawn considerable attention in the adult stroke world. A small number of trials in adult
      stroke patients and a small pilot trial in pediatric patients with upper limb weakness have
      shown that upper limb rehabilitation by telehealth is feasible and can be as effective as
      that delivered in the clinic.

      Based on this emerging evidence, we will test the feasibility of our CIMT protocol adapted
      for telerehabilitation. In a related study, we will refine our CIMT by soliciting the input
      of families and children who have undergone CIMT treatment, and the input of expert treating
      therapists and assessors regarding our protocol. In the current study, we will test this
      refined protocol in a pilot sample of five to seven children ages 1-10 years who have
      hemiplegic CP. We will evaluate whether the remotely delivered treatment maintains fidelity
      to the original version delivered in person; whether the treatment is feasible to deliver,
      and whether it is acceptable to families, therapists, and assessors. In addition, we will
      evaluate whether the remote assessment of fine and gross motor skills is feasible, reliable,
      and acceptable. These measures will be assessed by questionnaires, observation of assessment
      recordings, scoring of the outcome measure, and interviews of parents of and participating
      children (the primary stakeholders), as well as feedback from study assessors.

      Our long-term goal is to implement effective, accessible, intensive upper-limb interventions
      for children with hemiparesis, using delivery methods that are accessible, available, and
      feasible for families representing socioeconomic, geographic, and racial/ethnic diversity.
      This clinical research study is an important step toward clinical implementation through
      translation of an evidence-based intervention to a potentially more accessible, practical and
      equitable delivery method for families of children with CP.
    

Intervention name(s): Pediatric Constrained Induced Movement Therapy
Intervention type(s): Other
Intervention description(s): Constraint of the child's less-impaired upper extremity for first 17 days of treatment. Children wear a removable, lightweight constraint for the first 17 of 20 therapy sessions.
Intervention model: Single Group Assignment
Intervention model description: All enrolled children will receive the intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Motor impairments; Gross motor delays; Manual impairment; Upper extremity impairment