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

Plain Language Summary

Simplified for easier understanding

This study is testing whether early, intensive leg exercise therapy — starting in infancy — can improve walking ability in young children with spastic diplegia, a form of cerebral palsy where both legs are affected due to premature brain injury. The window of early life is critical for motor learning because the brain is highly plastic (adaptable), and early intensive therapy may help children develop stronger walking patterns before compensatory habits set in. Very young children (8 to 36 months) with periventricular white matter injury from premature birth will participate in a structured intensive leg exercise program. Progress will be tracked over time with gait analysis and motor assessments. You may be eligible if: - Your child is between 8 and 36 months of age - Your child has bilateral lower limb motor impairment - Your child has periventricular white matter injury from prematurity - Your child is able to stand with some support You may NOT be eligible if: - Your child has significant upper limb involvement (MACS level 3 or higher) - Your child has uncontrolled epilepsy or infantile spasms in the past 6 months - Your child has cardiovascular or musculoskeletal conditions that prevent intensive exercise - Your child has received botulinum toxin (Botox) injections in the legs within the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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