Perinatal StrokeNCT03672864
Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke
A study testing Intensive exercise in people with Perinatal Stroke, run by University of Alberta at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 36 months
- Conditions the study is for
- Perinatal Stroke
- What is being tested?
- Intensive exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesCanada
- Study dates
- 15 Feb 2019to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
University of Alberta
Edmonton, Alberta
Children's Hospital of Eastern Ontario
Ottawa, Ontario
About this study
Official title: 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.
Read the 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
- Being tested
- Intensive exercise
- Keywords
- Walking, Intensive exercise, Rehabilitation, Cerebral Palsy, Early intervention
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Group | Experimental | 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. Receives: Behavioral: Intensive exercise |
| Delay Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months, 6 months, 9 months, 12 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start15 Feb 2019
- Primary completion22 Apr 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal StrokeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Canada
- Responsible party
- Sponsor
- Investigators
- Jaynie Yang, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672864
- Sponsor's protocol ID
- Pro00078553
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2018
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hurd CL, Barnes M, Diot CM, Condliffe EG, Alazem H, Pritchard L, Zwicker JD, McCormick A, Watt MJ, Andersen J, Kirton A, Yang JF. Parent-therapist partnership to ELEVATE gross motor function in children with perinatal stroke: protocol for a mixed methods randomized controlled trial. BMC Pediatr. 2022 Aug 10;22(1):480. doi: 10.1186/s12887-022-03525-6.
PubMed 35948896
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Therapist Partnership to Provide Early, Intensive Exercise to Enhance Walking Outcomes in Children With Perinatal Stroke
- ClinicalTrials.gov ID
- NCT03672864
- Acronym / sponsor ID
- Pro00078553
- Conditions
- Perinatal Stroke
- Keywords
- Walking, Intensive exercise, Rehabilitation, Cerebral Palsy, Early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Brain Canada
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Immediate Group | Experimental | Behavioral: Intensive exerciseThe 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. |
| Delay Group | No intervention | –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. |
Who may qualify
- Ages
- 8 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive exerciseIntensive, 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. | Behavioural | Immediate Group |
Primary outcome
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.
7 secondary outcomes
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
Ankle joint angle at onset of stretch reflex - change from baseline
Time frame: 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
Resource use questionnaire
Time frame: Baseline
Resource use questionnaire
Time frame: 6 months
Resource use questionnaire
Time frame: 12 months
Young Children's Participation and Environment Measure (YC-PEM) - change from baseline
Time frame: 3 months, 6 months, 9 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Derived from this study: PubMed 35948896Hurd CL, Barnes M, Diot CM, Condliffe EG, Alazem H, Pritchard L, Zwicker JD, McCormick A, Watt MJ, Andersen J, Kirton A, Yang JF. Parent-therapist partnership to ELEVATE gross motor function in children with perinatal stroke: protocol for a mixed methods randomized controlled trial. BMC Pediatr. 2022 Aug 10;22(1):480. doi: 10.1186/s12887-022-03525-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaynie Yang principal investigator
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive exercise in people with Perinatal Stroke, run by University of Alberta at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (GMFM-66) - change from baseline (time frame: 3 months, 6 months, 9 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.