Physical, Functional and Neural Effects of Two Lower Extremity Exercise Protocols in Children With Cerebral Palsy
Condition: Cerebral Palsy; Children; Adolescents
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background:

        -  Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs
           and causes difficulty with leg movement and walking. Research has shown that exercise
           can help those with CP learn to move their arms better, but more research is needed to
           determine whether exercise programs can improve leg movements in people with CP.

        -  Walking on a treadmill with the help of a physical therapist has improved the treatment
           outcomes of some individuals with spinal cord injuries. Many children with CP already
           have physical therapy but still have trouble with walking and leg coordination. Two
           other kinds of exercise machines, a stationary bicycle and an elliptical machine, used
           in the home, may be able to help children with CP walk better and move their legs
           better.

      Objectives:

        -  To see how children with cerebral palsy (CP) move their legs differently from children
           without CP.

        -  To see if an exercise program can improve leg coordination in children with CP.

      Eligibility:

      - Children between 5 and 17 years of age who either have spastic diplegia CP or are healthy
      volunteers.

      Design:

        -  Children who are able and willing will have magnetic resonance imaging (MRI) scans at
           the start and the end of the study.

        -  During Part I of the study, participants will demonstrate their leg and muscle function
           with the following tests:

        -  Measurement of leg size and movement

        -  Combined camera motion study and electrical impulse evaluation to assess how well the
           participant walks (with or without an assistive device, as needed)

        -  Leg movement tests on an exercise bicycle and elliptical machine

        -  Tests of leg muscle strength, stiffness, and effectiveness

        -  Ultrasound scans of leg muscle

        -  Parents of participants will complete computer-based questionnaires about their child s
           motor abilities.

        -  A smaller group of participants will continue to Part II of the study, which involves
           regular exercise of 20 minutes a day, 5 days a week, for 3 months, on a stationary
           bicycle or elliptical trainer. Half of the group will start this exercise program
           immediately after the first part of the study, while the other half will wait 3 months
           before beginning the exercise program.

        -  During Part II, participants will return to the clinical center for two more sets of the
           tests and evaluations performed in Part I.
    

Detailed description: 
      Objectives:

      Our primary objectives are to: 1) characterize and compare lower extremity motor coordination
      in children with cerebral palsy (CP) across mobility levels and to children without CP; and
      2) evaluate the effects of two home-based exercise programs on motor coordination, as well as
      other physical, functional and neurological outcomes in children with CP. We hypothesize
      children with CP will exhibit significant coordination deficits compared to those without CP
      and that each exercise program will lead to significant improvements in outcomes.

      Study Population:

      Objective 1 will include 60 ambulatory children with spastic diplegic CP (20 in each of three
      mobility levels) and 20 children without CP within the same age range. Forty (40) children
      with CP will participate in Objective 2; 20 in each exercise group.

      Design:

      In Objective 1, the multiple measures taken at a single point in time will be compared across
      the three CP and the control groups. Children with CP from Objective 1 will be invited
      consecutively to participate in the exercise program (Objective 2), until enrollment is
      complete. Participation in Objective 2 lasts for 6 months. Subjects will be randomly assigned
      to use one of two novel lower extremity exercise devices: a motor-assisted cycle or an
      elliptical trainer. Children will exercise for 20 minutes, 5 days a week for 12 consecutive
      weeks. The major goal of each is to increase the ability to cycle or step at a rapid pace
      (the target goal is 40 RPM), with resistance added once speed goals are attained and
      thereafter progressed gradually. The timing of the exercise period (immediate vs. delayed for
      3 months) will also be randomly assigned allowing assessors to be masked to group assignment.

      Outcome Measures:

      The primary outcome is the difference (Objective 1) or pre to post-exercise change (Objective
      2) in coordination as measured by the fastest active (voluntary) cadence with each device.
      Additional coordination measures include cadence at free speed, variability in cadence, and
      EMG reciprocation vs. synchronization. Selective Control Assessment for the Lower extremity
      (SCALE), strength and spasticity tests and ultrasound measures of muscle size will be
      assessed at each time point. These will be compared across groups and before and after the
      two exercise programs. Functional outcomes include gait speed and two validated
      computer-based questionnaires. Neural outcomes include selected measures of gray and white
      matter connectivity as assessed with fcMRI and DTI, respectively.
    

Intervention name(s): Physical Exercise
Intervention type(s): Other
Intervention description(s): Children will be assigned either an elliptical machine or cycle to take home. Each exercise will be performed for 20 minutes per day, 5 days per week for a period of 12 consecutive weeks, or 60 sessions in all. To avoid excessive fatigue or over-training effects, children are asked to adhere to this exact schedule and not to exercise more than this. Children are asked to complete as many of the sessions as they can. To allow for sick days or vacation during the program, the duration of the training can be extended up to 2 more weeks if needed to try to complete all 60 sessions. Compliance (percent sessions completed) will be correlated with outcomes in the statistical analyses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coordination; Neuroimaging; Motion Analysis; Locomotor