Clinical trial NCT03672864: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Perinatal Stroke
Keywords: Walking
Intensive exercise
Rehabilitation
Cerebral Palsy
Early intervention
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Brain Canada
First posted: 2018-09-17
Enrollment: 18
Sex: ALL
Minimum age (years): 8
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gross Motor Function Measure (GMFM-66) - change from baseline
timeFrame: 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: The Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP) - change from baseline
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Ankle joint angle at onset of stretch reflex - change from baseline
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Ankle joint angle at full dorsiflexion - change from baseline
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Resource use questionnaire
timeFrame: Baseline
measure: Resource use questionnaire
timeFrame: 6 months
measure: Resource use questionnaire
timeFrame: 12 months
measure: Young Children's Participation and Environment Measure (YC-PEM) - change from baseline
timeFrame: 3 months, 6 months, 9 months, 12 months
Other outcomes:
measure: Qualitative study using Interpretative Description methodology
timeFrame: Immediately before and after the intervention
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: University of Alberta
name: Jaynie Yang
role: PRINCIPAL_INVESTIGATOR
References:
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.