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

Primary Purpose

Perinatal Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intensive exercise
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perinatal Stroke focused on measuring Walking, Intensive exercise, Rehabilitation, Cerebral Palsy, Early intervention

Eligibility Criteria

8 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alberta Children's HospitalRecruiting
  • University of AlbertaRecruiting
  • Children's Hospital of Eastern OntarioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate Group

Delay Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 13, 2018
Last Updated
May 12, 2023
Sponsor
University of Alberta
Collaborators
Brain Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03672864
Brief Title
Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke
Official Title
Parent Therapist Partnership to Provide Early, Intensive Exercise to Enhance Walking Outcomes in Children With Perinatal Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Brain Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Stroke
Keywords
Walking, Intensive exercise, Rehabilitation, Cerebral Palsy, Early intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled trial
Masking
Outcomes Assessor
Masking Description
Assessing therapists are masked to the child's group assignment.
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Delay Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gross Motor Function Measure (GMFM-66) - change from baseline
Description
A 66 item criterion referenced observational measure of gross motor skills designed for children with cerebral palsy.
Time Frame
3 months, 6 months, 9 months, 12 months
Secondary Outcome Measure Information:
Title
The Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP) - change from baseline
Description
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.
Time Frame
3 months, 6 months, 9 months, 12 months
Title
Ankle joint angle at onset of stretch reflex - change from baseline
Description
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.
Time Frame
3 months, 6 months, 9 months, 12 months
Title
Ankle joint angle at full dorsiflexion - change from baseline
Description
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.
Time Frame
3 months, 6 months, 9 months, 12 months
Title
Resource use questionnaire
Description
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.
Time Frame
Baseline
Title
Resource use questionnaire
Description
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.
Time Frame
6 months
Title
Resource use questionnaire
Description
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.
Time Frame
12 months
Title
Young Children's Participation and Environment Measure (YC-PEM) - change from baseline
Description
A questionnaire completed by parents to assess participation in three settings: home, daycare/preschool, and the community.
Time Frame
3 months, 6 months, 9 months, 12 months
Other Pre-specified Outcome Measures:
Title
Qualitative study using Interpretative Description methodology
Description
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.
Time Frame
Immediately before and after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Barnes
Phone
780-492-4858
Email
carre@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jaynie Yang
Phone
780-492-2894
Email
jaynie@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaynie Yang
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christa Diot
Phone
403 955 5736
Ext
4359
Email
Christa.Diot@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Michelle Barnes
Phone
780-492-4858
Email
carre@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Elizabeth Condliffe, MD, Phd
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Barnes
Phone
780-492-4858
Email
carre@ualberta.ca
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Larin
Phone
613-737-7600
Ext
4359
Email
MLarin@cheo.on.ca
First Name & Middle Initial & Last Name & Degree
Michelle Barnes
Phone
780-492-4858
Email
carre@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Anna McCormick, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35948896
Citation
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.
Results Reference
derived

Learn more about this trial

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

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