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

March 1, 2024 updated by: University of Alberta

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.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
      • Edmonton, Alberta, Canada
        • Recruiting
        • University of Alberta
        • Contact:
    • Ontario
      • Ottawa, Ontario, Canada
        • Recruiting
        • Children's Hospital of Eastern Ontario
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna McCormick, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 3 years (Child)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jaynie Yang, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2019

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

September 13, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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