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Parent Therapist Partnership to Provide Early, Intensive Exercise to Enhance Walking Outcomes in Children With Perinatal Stroke
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.
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.
Age
0 - 3 years
Sex
ALL
Healthy Volunteers
No
Alberta Children's Hospital
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Start Date
February 15, 2019
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
May 6, 2025
18
ACTUAL participants
Intensive exercise
BEHAVIORAL
Lead Sponsor
University of Alberta
Collaborators
NCT05346887
NCT04233710
Data Source & Attribution
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