Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia
Condition: Spastic Diplegia
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      This is a randomized controlled trial comparing 3 months of intensive leg exercise to
      standard physiotherapy care for the improvement of motor function in the legs in young
      children with spastic diplegia.
    

Detailed description: 
      Children born prematurely are at risk of brain injury that can result in cerebral palsy(CP),
      most often affecting the legs, called spastic diplegia. Current treatment is largely passive,
      including leg braces, repeated injection of a paralyzing agent (Botox) in muscles that are
      abnormally active, and surgery as deformities occur. Active, physical therapy for weak
      muscles is infrequent, occurring twice a month or less. Yet, recent work with mammals show
      that early brain injury can be alleviated by intensive exercise therapy, but only while the
      animal is very young. Building on the success with early, intensive therapy for children with
      perinatal (around birth) stroke, the investigators will apply intensive therapy for the legs
      in children with diplegia. Children (8 mo - 3 yr old) will be randomly assigned to start
      treatment immediately or delay treatment for 3 mo. The delay period controls for improvement
      without treatment. These children will also receive treatment after the delay period. The
      therapy will be guided by physical therapists, and similar to the project on perinatal
      stroke. Children who live beyond commuting distance from the centres will form a 3rd group,
      whose parents will be coached by therapists to train the child at home. This group will show
      whether parents can be as effective as a therapist. Finally, when all children turn 4 yr old,
      they will be compared to other 4-yr-old children with the same diagnosis, but no training, to
      determine if there are long term benefits. The investigators anticipate that like the
      children with perinatal stroke, early intensive exercise will improve mobility, facilitate
      earlier and better walking, and that the effects will be enduring.
    

Intervention name(s): Intensive leg training with a physical therapist
Intervention type(s): Behavioral
Intervention description(s): Intensive, self initiated activities of the lower extremities including walking over ground or on a treadmill (with or without support), kicking, jumping, standing balance, climbing stairs and slopes and other leg activities. Small weights will be added to the ankle and foot to increase the intensity of the exercise. A physical therapist will supervise sessions.
Other intervention name(s): Therapist training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to receive 3 months of intervention or 3 months of observation. Participants in the observation group will be offered the intervention once the observation period is complete
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Physical Therapy; Rehabilitation