Asymmetrical Gait Training After Pediatric Stroke
Condition: Stroke; Hemiplegia
MeSH terms: Stroke; Hemiplegia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purposes of this pilot research study are 1. To begin to test if two different types of
      physical therapy might have different results in children and adolescents who have had a
      prior stroke, and 2. To determine if either type of physical therapy causes changes in the
      brain signals that control leg muscles. All participants will receive physical therapy 3
      times per week for 8 weeks. Half of the participants will receive typical physical therapy,
      such as walking practice, muscle strengthening, and balance training. Half of the
      participants will receive asymmetrical gait training physical therapy, which uses new
      technology to train each leg differently during walking practice. After enrolling,
      participants will be randomly assigned to the type of therapy. Measurements will be taken
      before, during, and after the 8 weeks of physical therapy. These include walking tests to
      measure symmetry, walking speed and daily step activity, and brain tests to measure the
      strength of the signals from the brain to the leg muscles. One blood test is also taken to
      identify if certain genetic factors affect how each child responds to the physical therapy.
    

Detailed description: 
      Effective rehabilitation after acquired brain injury is essential for reducing the impact of
      the leading cause of pediatric disability in the United States. Neuroplastic changes in
      response to physical therapy are likely different in children compared to adults because
      children are continuing to experience developmental brain maturation while also experiencing
      the neural changes associated with injury and rehabilitation. The interaction between these
      two processes is poorly understood but presumably critical for maximizing long term outcomes.
      Using biomarkers to measure and predict rehabilitation-induced changes will improve
      rehabilitation prognosis and will facilitate the development of rehabilitation interventions
      that optimize neuroplastic potential in children. The objectives of this pilot study are to
      investigate the motor and neural responses to two different rehabilitation programs in
      children and adolescents with chronic hemiplegia from prior stroke. Participants will be
      randomly assigned to receive conventional physical therapy or an asymmetrical gait training
      program. Conventional physical therapy will include activities such as gait and balance
      training and muscle strengthening. The asymmetrical gait training program uses new technology
      to train each leg at a different speed during walking practice. Measurements of motor and
      neural function will occur at five timepoints before, during and after treatment. Motor
      function measures will include gait symmetry ratios, walking speed, community step activity,
      and participant and caregiver ratings on self-identified walking goals. Neural measures will
      include motor response characteristics of muscle contractions elicited in two lower extremity
      muscles by transcranial magnetic stimulation of the injured cortex. We will also establish a
      genetic database to identify the presence or absence of two genetic variants [Apolipoprotein
      E (ApoE Є4) and val66met Brain-derived neurotropic factor (BDNF) polymorphisms] associated
      with decreased potential for neuroplasticity for planning future investigations. The results
      will be used to inform the design of larger studies evaluating physical therapy treatments
      that maximize the capacity of the child's brain to change after neurological injury and
      identifying predictors of rehabilitation-induced neuroplasticity in children.
    

Intervention name(s): Conventional physical therapy; Asymmetrical gait training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric stroke; hemiplegia; physical therapy; gait training; transcranial magnetic stimulation; gait asymmetry