NCT03672864

Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke

Parent Therapist Partnership to Provide Early, Intensive Exercise to Enhance Walking Outcomes in Children With Perinatal Stroke

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 8 Months – 36 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Perinatal Stroke

Interventions

Type	Name	Description
BEHAVIORAL	Intensive exercise	Intensive, child-initiated movement of the lower extremity: 1 hour/day, 4 days/week, 2 sessions delivered by a physical therapist, 2 delivered by a parent. All activities are play based, and exercise intensity is enhanced by small weights placed on the dorsum of the foot and the ankle of the affected limb. Intervention is delivered over 12 weeks for a target of 48 hours of training.

Timeline

• Start date: 2019-02-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2018-09-17
• Last updated: 2025-05-06

Locations

3 sites across 1 country: Canada