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Active, Not Recruiting

NCT Number: NCT03672864

Parent Therapist Partnership to Provide Early, Intensive Exercise in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Perinatal Stroke Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

8 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive exercise

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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. 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.

  7. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Brain Canada

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2018
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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