Active — Not RecruitingNot Applicable

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

Canada60 participantsStarted 2019-01-28

Plain-language 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.

Who can participate

Age range8 Months – 36 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Gross Motor Functional Measure - 66 Items (GMFM-66)

Timeframe: From Baseline to 6 months

Trial details

NCT IDNCT03672877

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Spastic Diplegia trials