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

Perinatal Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03672864
• Other study ID #: Pro00078553
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Perinatal Stroke
• Stroke

Intervention

Behavioral:
• Intensive exercise
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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Brain Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative study using Interpretative Description methodology	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
Primary	Gross Motor Function Measure (GMFM-66) - change from baseline	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	The Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP) - change from baseline	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
Secondary	Ankle joint angle at onset of stretch reflex - change from baseline	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
Secondary	Ankle joint angle at full dorsiflexion - change from baseline	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
Secondary	Resource use questionnaire	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
Secondary	Resource use questionnaire	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
Secondary	Resource use questionnaire	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
Secondary	Young Children's Participation and Environment Measure (YC-PEM) - change from baseline	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