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

NCT ID: NCT03672864

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2026-12-31

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.

Conditions

Perinatal Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate Group

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.

Group Type: EXPERIMENTAL

Intensive exercise

Intervention Type: 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.

Delay Group

The group will be followed for 6 months with no intervention. After 6 months the group will be given the opportunity to receive the same intensive exercise intervention as the Immediate group. The group will be followed for 3 months following the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brain Canada

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaynie Yang

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35948896 (View on PubMed)

Other Identifiers

Pro00078553

Identifier Type: -

Identifier Source: org_study_id