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Clinical Trial Summary

A prospective, single blind, parallel group, randomized control trial to determine if early, intensive lower extremity activity delivered by a physical therapist and a parent in partnership improves gross motor function more than usual care.


Clinical Trial Description

A mixed-methods randomized controlled trial at 3 healthcare centres: Edmonton, Calgary and Ottawa. The period of participation for each child is 12 months. The Immediate Group will have 3 months of intervention and 9 months follow-up. The Delay Group will be followed for 6 months (waitlist-control period), then given the opportunity to receive the same intervention and followed for 3 months after the intervention. The intervention will be delivered by clinicians in the rehabilitation centres in partnership with the child's parents. Therapists will provide training 2 days a week and will coach the parents to provide the training at home for 2 days a week. The intervention is ELEVATE (Engaging the Lower Extremity Via Active Therapy Early) and consists of child-initiated, intensive leg activities for one hour a day, four days a week for 12 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03672864
Study type Interventional
Source University of Alberta
Contact Michelle Barnes
Phone 780-492-4858
Email carre@ualberta.ca
Status Recruiting
Phase N/A
Start date February 15, 2019
Completion date February 2026

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