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

Not Applicable

Active, not recruiting

• Conditions: Perinatal Stroke
• Interventions: Behavioral: Intensive exercise

• Registration Number: NCT03672864
• Lead Sponsor: University of Alberta

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Study Start: 2019-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Group	Intensive exercise	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.

Primary Outcome Measures

Name	Time	Method
Gross Motor Function Measure (GMFM-66) - change from baseline	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 Outcome Measures

Name	Time	Method
Young Children's Participation and Environment Measure (YC-PEM) - change from baseline	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.
Ankle joint angle at onset of stretch reflex - change from baseline	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.
Ankle joint angle at full dorsiflexion - change from baseline	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.
Resource use questionnaire	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.
The Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP) - change from baseline	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.

Trial Locations

Locations (3)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada