RecruitingNot ApplicableNCT03672877

Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia

Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia From Encephalopathy of Prematurity


Sponsor

University of Alberta

Enrollment

60 participants

Start Date

Jan 28, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 MonthsMax Age: 36 Months

Inclusion Criteria3

  • Bilateral motor impairment of the lower extremities
  • Periventricular white matter injury from encephalopathy of prematurity
  • Able to stand with some support

Exclusion Criteria4

  • 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

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Interventions

BEHAVIORALIntensive exercise

Intensive, child-initiated activities of the lower extremities including walking (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. Sessions will be one hour long, 4 days a week. A physical therapist or designate will supervise sessions.


Locations(2)

Alberta Children's Hospital

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

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NCT03672877


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