Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia

NCT ID: NCT03672877

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-28
• Study Completion Date: 2027-03-31

Brief Summary

This is a randomized controlled trial, comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of gross motor function in young children with spastic diplegia.

Detailed Description

Children born prematurely are at risk of brain injury that can result in cerebral palsy, most often affecting both legs. Current treatment is largely passive, including leg braces, repeated injection of a paralyzing agent (botulinum toxin) in muscles that are abnormally active, and surgery as deformities occur. Active, physical therapy for weak muscles is infrequent, occurring twice a month or less. Yet, recent work in mammals show that early brain injury can be alleviated by intensive exercise therapy, but only while the animal is very young.

Building on our success with early, intensive therapy for children with perinatal stroke, we will apply intensive therapy for the legs in children with cerebral palsy involving both legs. Children (8 mo - 3 yr old) will be randomly assigned to start treatment immediately or delay treatment for 6 months. The delay period controls for improvement without treatment. The children in the Delay Group will have the option to receive the same treatment after the delay period. The therapy will be guided by physical therapists, and centered on play. Measures will be taken before, during and after the delay and treatment periods. Measures will include clinical scores of motor development, proficiency of walking, participation at home, and physiological measures of motor and sensory function. All children will be followed until they turn 4 yr old, to determine if there are long term benefits. The cost-effectiveness of the intervention will be evaluated by a health economist. We anticipate that early intensive exercise will improve mobility, facilitate earlier and better walking, and that the effects will be enduring.

Conditions

Spastic Diplegia; Periventricular Leukomalacia

Study Design

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

Study Groups

Immediate training group

Children will participate in intensive exercise intervention for 3 months and will be followed for 9 months following the intervention

Group Type: EXPERIMENTAL

Intensive exercise

Intervention Type: BEHAVIORAL

Intensive, child-initiated activities of the lower extremities including walking (with or without support), kicking, jumping, standing balance, climbing stairs and slopes and other leg activities. Small weights will be added to the ankle and foot to increase the intensity of the exercise. Sessions will be one hour long, 4 days a week. A physical therapist or designate will supervise sessions.

Delay training group

Children will be assessed for 6 months with no intervention. After the 6 month period children will be given the same intervention as the immediate group and followed for 3 months after the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intensive exercise

Intensive, child-initiated activities of the lower extremities including walking (with or without support), kicking, jumping, standing balance, climbing stairs and slopes and other leg activities. Small weights will be added to the ankle and foot to increase the intensity of the exercise. Sessions will be one hour long, 4 days a week. A physical therapist or designate will supervise sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Bilateral motor impairment of the lower extremities
• Periventricular white matter injury from encephalopathy of prematurity
• Able to stand with some support

Exclusion Criteria

• Substantial upper extremity involvement - Manual Abilities Classification System (MACS) Level ≥3
• Uncontrolled epilepsy or infantile spasms in the past 6 months
• Cardiovascular or musculoskeletal complications that preclude participation in intensive exercise
• Botulinum toxin-A (BTX-A) injections in the legs in the last 6 months

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

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaynie Yang, Phd

Role: PRINCIPAL_INVESTIGATOR

Universtiy of Alberta

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status: RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Donna Livingstone, BScPT

Role: CONTACT

carre@ualberta.ca

780-492-4858

Facility Contacts

Michelle Barnes, BScPT

Role: primary

carre@ualberta.ca

780-492-4858

Michelle Barnes, BScPT

Role: primary

carre@ualberta.ca

780-492-4858

Other Identifiers

Pro00080569

Identifier Type: -

Identifier Source: org_study_id