- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michelle Barnes
- Phone Number: 780-492-4858
- Email: carre@ualberta.ca
Study Contact Backup
- Name: Jaynie Yang
- Phone Number: 780-492-2894
- Email: jaynie@ualberta.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T3B 6A8
- Recruiting
- Alberta Children's Hospital
-
Contact:
- Michelle Barnes
- Phone Number: 780-492-4858
- Email: carre@ualberta.ca
-
Contact:
- Christa Diot
- Phone Number: 4359 403 955 5736
- Email: Christa.Diot@albertahealthservices.ca
-
Principal Investigator:
- Elizabeth Condliffe, MD, Phd
-
Edmonton, Alberta, Canada
- Recruiting
- University of Alberta
-
Contact:
- Michelle Barnes
- Phone Number: 780-492-4858
- Email: carre@ualberta.ca
-
-
Ontario
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Ottawa, Ontario, Canada
- Recruiting
- Children's Hospital of Eastern Ontario
-
Contact:
- Michelle Barnes
- Phone Number: 780-492-4858
- Email: carre@ualberta.ca
-
Contact:
- Michelle Larin
- Phone Number: 4359 613-737-7600
- Email: MLarin@cheo.on.ca
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Principal Investigator:
- Anna McCormick, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Group
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.
|
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.
|
No Intervention: Delay Group
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
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.
|
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
Time Frame: 3 months, 6 months, 9 months, 12 months
|
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
Time Frame: 3 months, 6 months, 9 months, 12 months
|
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
Time Frame: 3 months, 6 months, 9 months, 12 months
|
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
Time Frame: Baseline
|
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
Time Frame: 6 months
|
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
Time Frame: 12 months
|
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
Time Frame: 3 months, 6 months, 9 months, 12 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative study using Interpretative Description methodology
Time Frame: Immediately before and after the intervention
|
A concurrent qualitative study will be conducted to gain insight into the perspective of parents participating in the administration of the ELEVATE intervention and their experiences as a partner in the early, intensive rehabilitation.
Semi-structured, individual interviews will be conducted by a researcher with a subset of parents.
|
Immediately before and after the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jaynie Yang, University of Alberta
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00078553
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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