Parent Therapist Partnership to Provide Early, Intensive Exercise to Enhance Walking Outcomes in Children With Perinatal Stroke
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Perinatal Stroke
- Sponsor
- University of Alberta
- Enrollment
- 18
- Locations
- 3
- Primary Endpoint
- Gross Motor Function Measure (GMFM-66) - change from baseline
- Status
- Active, Not Recruiting
- Last Updated
- 12 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •children ages 8 months to 3 years
- •medical history and physical exam consistent with perinatal stroke
- •hemiparesis in the upper and/or lower extremity
- •parental agreement to adhere to the training and testing schedule
Exclusion Criteria
- •bilateral motor impairment
- •epileptic seizures that could interfere with training
- •cognitive, behavioural or developmental impairments that preclude participation in the protocol
- •botulinum toxin A injections or surgery in the lower extremities within the previous six months
- •concurrent casting during the intervention phase (including constraint-induced movement therapy with casting)
- •diagnosis associated with neurological/developmental regression
- •parent unable to communicate (verbal and written) in English or French
Outcomes
Primary Outcomes
Gross Motor Function Measure (GMFM-66) - change from baseline
Time Frame: 3 months, 6 months, 9 months, 12 months
A 66 item criterion referenced observational measure of gross motor skills designed for children with cerebral palsy.
Secondary Outcomes
- Young Children's Participation and Environment Measure (YC-PEM) - change from baseline(3 months, 6 months, 9 months, 12 months)
- Ankle joint angle at onset of stretch reflex - change from baseline(3 months, 6 months, 9 months, 12 months)
- Ankle joint angle at full dorsiflexion - change from baseline(3 months, 6 months, 9 months, 12 months)
- Resource use questionnaire(12 months)
- The Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP) - change from baseline(3 months, 6 months, 9 months, 12 months)