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

Study 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.

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

Conditions
-----------------
Perinatal Stroke

Intervention / Treatment
-----------------
* Behavioral: Intensive exercise


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Months
Maximum Age: 36 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Group<br>The intervention is intensive exercise, delivered over 12 weeks beginning on admission to the study. The group will then be followed for 9 months post intervention. | Behavioral: Intensive exercise<br>* 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.<br>|
| No Intervention: Delay Group<br>The group will be followed for 6 months with no intervention. After 6 months the group will be given the opportunity to receive the same intensive exercise intervention as the Immediate group. The group will be followed for 3 months following the intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measure (GMFM-66) - change from baseline | A 66 item criterion referenced observational measure of gross motor skills designed for children with cerebral palsy. | 3 months, 6 months, 9 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP) - change from baseline | A questionnaire completed by parents including 5 scales: 1) daily activities, 2) movement and balance, 3) pain and hurt, 4) fatigue, and 5) eating activities. | 3 months, 6 months, 9 months, 12 months | 
| Ankle joint angle at onset of stretch reflex - change from baseline | Ankle joint angle caused by the stretch reflex will be measured with the Portable Spasticity Assessment Device (PSAD). A hand-held segment of the device is applied to the foot segment to measure the motion of the limb. Disposable, surface electromyographic electrodes are applied to the skin of the limb to measure the muscle activity. | 3 months, 6 months, 9 months, 12 months | 
| Ankle joint angle at full dorsiflexion - change from baseline | Ankle joint angle at the extreme of dorsiflexion will be measured with the Portable Spasticity Assessment Device (PSAD). A hand-held segment of the device is applied to the foot segment to measure the motion of the limb. Disposable, surface electromyographic electrodes are applied to the skin of the limb to ensure the muscle is relaxed during the measurement. | 3 months, 6 months, 9 months, 12 months | 
| Resource use questionnaire | All health, community, and social service use will be collected at baseline and every six months throughout the one year study period using the Resource Use Questionnaire, a tool validated for use in participants with neurodevelopmental disabilities. Costs related to lower extremity therapy as well as resources used for treatment and management of the child's cerebral palsy will be included over the study period. | Baseline | 
| Resource use questionnaire | All health, community, and social service use will be collected at baseline and every six months throughout the one year study period using the Resource Use Questionnaire, a tool validated for use in participants with neurodevelopmental disabilities. Costs related to lower extremity therapy as well as resources used for treatment and management of the child's cerebral palsy will be included over the study period. | 6 months | 
| Resource use questionnaire | All health, community, and social service use will be collected at baseline and every six months throughout the one year study period using the Resource Use Questionnaire, a tool validated for use in participants with neurodevelopmental disabilities. Costs related to lower extremity therapy as well as resources used for treatment and management of the child's cerebral palsy will be included over the study period. | 12 months | 
| Young Children's Participation and Environment Measure (YC-PEM) - change from baseline | A questionnaire completed by parents to assess participation in three settings: home, daycare/preschool, and the community. | 3 months, 6 months, 9 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Walking, Intensive exercise, Rehabilitation, Cerebral Palsy, Early intervention