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Open Access 01-12-2022 | Stroke | Study protocol

Parent-therapist partnership to ELEVATE gross motor function in children with perinatal stroke: protocol for a mixed methods randomized controlled trial

Authors: Caitlin L. Hurd, Michelle Barnes, Christa M. Diot, Elizabeth G. Condliffe, Hana Alazem, Lesley Pritchard, Jennifer D. Zwicker, Anna McCormick, Man-Joe Watt, John Andersen, Adam Kirton, Jaynie F. Yang

Published in: BMC Pediatrics | Issue 1/2022

Abstract

Background

There is increasing evidence for early, active rehabilitation to enhance motor function following early brain injury. This is clear for interventions targeting the upper extremity, whereas passive treatment approaches for the lower extremity persist. The purpose of this trial is to evaluate the effectiveness of early, intensive rehabilitation targeting the lower extremity and delivered in a parent-therapist partnership model for children with perinatal stroke.

Methods

We describe a protocol for a waitlist-control, single-blind, mixed methods effectiveness randomized controlled trial, with an embedded qualitative study using interpretative description. Participants are children with perinatal stroke aged eight months to three years with signs of hemiparesis. Participants will be randomly allocated to an immediate ELEVATE (Engaging the Lower Extremity Via Active Therapy Early) intervention group, or a waitlist-control group, who will receive usual care for six months. The ELEVATE intervention involves one hour of training four days per week for 12 weeks, with a pediatric therapist and a parent or guardian each delivering two sessions per week. The intervention targets the affected lower extremity by progressively challenging the child while standing and walking. The primary outcome measure is the Gross Motor Function Measure-66. Secondary outcomes include the Pediatric Quality of Life Inventory™, Young Children's Participation and Environment Measure, and an instrumented measure of spasticity. A cost-effectiveness analysis and qualitative component will explore benefit to costs ratios and parents’ perspectives of early, intensive rehabilitation, and their role as a partner in the rehabilitation, respectively.

Discussion

This study has the potential to change current rehabilitation for young children with perinatal stroke if the ELEVATE intervention is effective. The parent interviews will provide further insight into benefits and challenges of a partnership model of rehabilitation. The mixed methods design will enable optimization for transfer of this collaborative approach into physical therapy practice.

Trial registration

ClinicalTrials.gov NCT03672864. Registered 17 September 2018.

Available only for authorised users

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Title: Parent-therapist partnership to ELEVATE gross motor function in children with perinatal stroke: protocol for a mixed methods randomized controlled trial
Authors: Caitlin L. Hurd
Michelle Barnes
Christa M. Diot
Elizabeth G. Condliffe
Hana Alazem
Lesley Pritchard
Jennifer D. Zwicker
Anna McCormick
Man-Joe Watt
John Andersen
Adam Kirton
Jaynie F. Yang
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Stroke
Physical Therapy
Published in: BMC Pediatrics / Issue 1/2022
Electronic ISSN: 1471-2431
DOI: https://doi.org/10.1186/s12887-022-03525-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Parent-therapist partnership to ELEVATE gross motor function in children with perinatal stroke: protocol for a mixed methods randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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