Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy: A Pilot Study
Condition: Developmental Delay; Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      - People who have cerebral palsy often have difficulty walking and moving their legs.
      Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which
      means that early motor skill development can be affected and can have repercussions for later
      development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury)
      have shown that it is important to start intensive therapy soon after the injury, and it may
      be true that starting intensive therapy at a young age will be helpful for children with
      cerebral palsy. Researchers are interested in testing the effectiveness of a special body
      weight support system for mobility training in young children who have or are at risk for
      cerebral palsy.

      Objectives:

      - To study the effectiveness of a mobility training program on the motor skills of young
      children who have or are at risk for cerebral palsy.

      Eligibility:

      - Children between 12 and 36 months of age who have delayed motor skills and either have been
      diagnosed with cerebral palsy or show evidence of spasticity or brain damage.

      Design:

        -  This study involves two 6-week study phases: a baseline phase and a mobility training
           program.

        -  Participants will be screened with a physical examination and medical history.

        -  During the baseline phase, participants will have mobility testing sessions once every 2
           weeks. These tests will measure motor development and ability, including ease and speed
           of walking.

        -  Participants' parents/guardians will receive a mobility sensor for the child to wear at
           home for at least 6 hours (awake time) to measure activity and mobility levels outside
           of the testing sessions.

        -  After 6 weeks of baseline testing, participants will have 6 weeks of mobility training
           for 30 minutes 3 days per week. Training will involve motor tasks with weight support,
           conducted by a pediatric physical therapist. Activities may include walking, climbing
           inclines or steps, or squatting to reach toys. All sessions will be videotaped.

        -  To evaluate the effects of the therapy program, participants will have testing sessions
           every 2 weeks.

        -  Parents/guardians will also complete questionnaires to provide feedback on the
           effectiveness of the therapy program.
    

Detailed description: 
      The purpose of this pilot study is to test the feasibility and effects of a functional
      mobility training program on the motor ability and physical activity of young children who
      are developmentally delayed and at risk for cerebral palsy (CP). The study includes a sample
      of 10 participants between 12-36 months of age who have at least a 4 month motor delay and
      are at risk for CP in a single-subject research design with repeated measures during baseline
      and intervention phases. Participants will have biweekly assessments during the 6 week
      baseline phase and the subsequent 6 week mobility training phase, followed by a final
      assessment after 6 weeks of treatment withdraw. Assessments and training will occur in the
      Functional and Applied Biomechanics (FAB) section. The mobility training program consists of
      three days per week of 30 minute treatment sessions using dynamic body weight support during
      a variety of functional motor tasks. Children will be assisted, but not limited, by the
      dynamic weight support system while they are encouraged to participate in a variety of
      age-appropriate mobility tasks. It is hypothesized that this system combined with the
      functional activity practice will facilitate the development of postural control and
      strength, and thereby improve walking ability. The primary outcome measures are completion
      rate and gross motor ability as measured by the Gross Motor Function Measure (GMFM).
      Secondary outcome measures include the amount of gross motor delay as measured by the Bayley
      Motor Scale (BMS),, the Functional Mobility Scale (FMS), spatiotemporal gait measures, and
      amount of physical activity in daily life. Results of this pilot study will be used to refine
      the mobility training program, evaluate the appropriateness of the selected outcome measures,
      and to provide preliminary data for a larger scale clinical trial.
    

Intervention name(s): mobility training with dynamic body weight support
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mobility; Developmental Delay; Cerebral Palsy; Early Walking; Postural Control