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

University of Alberta

Status: Active, not recruiting

Conditions: Perinatal Stroke

Treatments: Behavioral: Intensive exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03672864

Pro00078553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 8 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Immediate Group

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive exercise

Delay Group

No Intervention group

Description:

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.