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Recruiting NCT03672877
Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia
Trial Parameters
Condition Spastic Diplegia
Sponsor University of Alberta
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 8 Months
Max Age 36 Months
Start Date 2019-01-28
Completion 2026-03-31
All Conditions
Interventions
Intensive exercise
Brief Summary
This is a randomized controlled trial, comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of gross motor function in young children with spastic diplegia.
Eligibility Criteria
Inclusion Criteria: * Bilateral motor impairment of the lower extremities * Periventricular white matter injury from encephalopathy of prematurity * Able to stand with some support Exclusion Criteria: * Substantial upper extremity involvement - Manual Abilities Classification System (MACS) Level ≥3 * Uncontrolled epilepsy or infantile spasms in the past 6 months * Cardiovascular or musculoskeletal complications that preclude participation in intensive exercise * Botulinum toxin-A (BTX-A) injections in the legs in the last 6 months