Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia

NCT ID: NCT03166293

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-11-03

Brief Summary

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

Detailed Description

Children born prematurely are at risk of brain injury that can result in cerebral palsy(CP), most often affecting the legs, called spastic diplegia. Current treatment is largely passive, including leg braces, repeated injection of a paralyzing agent (Botox) 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 with mammals show that early brain injury can be alleviated by intensive exercise therapy, but only while the animal is very young. Building on the success with early, intensive therapy for children with perinatal (around birth) stroke, the investigators will apply intensive therapy for the legs in children with diplegia. Children (8 mo - 3 yr old) will be randomly assigned to start treatment immediately or delay treatment for 3 mo. The delay period controls for improvement without treatment. These children will also receive treatment after the delay period. The therapy will be guided by physical therapists, and similar to the project on perinatal stroke. Children who live beyond commuting distance from the centres will form a 3rd group, whose parents will be coached by therapists to train the child at home. This group will show whether parents can be as effective as a therapist. Finally, when all children turn 4 yr old, they will be compared to other 4-yr-old children with the same diagnosis, but no training, to determine if there are long term benefits. The investigators anticipate that like the children with perinatal stroke, early intensive exercise will improve mobility, facilitate earlier and better walking, and that the effects will be enduring.

Conditions

Spastic Diplegia

Study Design

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

Study Groups

Immediate Group

Children will participate in intensive leg training with a physical therapist 1 hour/day, 4 days/week for 12 weeks. Children will continue to receive standard physical therapy care. Children will be followed for one year from the time of enrollment in the study.

Group Type: EXPERIMENTAL

Intensive leg training with a physical therapist

Intervention Type: BEHAVIORAL

Intensive, self initiated activities of the lower extremities including walking over ground or on a treadmill (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. A physical therapist will supervise sessions.

Delay Group

Children will be monitored for 3 months with no intervention. Children will participate in intensive leg training with a physical therapist after the 3 month delay period. Training will be 1 hour/day, 4 days/week for 12 weeks. They will continue to receive standard care throughout. Children will be followed for one year from the time of enrollment in the study.

Group Type: EXPERIMENTAL

Intensive leg training with a physical therapist

Intervention Type: BEHAVIORAL

Intensive, self initiated activities of the lower extremities including walking over ground or on a treadmill (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. A physical therapist will supervise sessions.

Interventions

Intensive leg training with a physical therapist

Intensive, self initiated activities of the lower extremities including walking over ground or on a treadmill (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. A physical therapist will supervise sessions.

Intervention Type: BEHAVIORAL

Other Intervention Names

Therapist training

Eligibility Criteria

Inclusion Criteria

• children aged 8 mo - 3 yr old
• Evidence of periventricular white matter injury on diagnostic imaging
• clinical evidence of spastic diplegia

Exclusion Criteria

• born before gestational age of 25 weeks
• birth weight <1000g (to exclude confounds related to extreme prematurity and low birth weights)
• MRI evidence of diffuse injury to the cerebral or cerebellar cortex
• uncontrolled epilepsy or infantile spasms in the past 6 months (contraindication for TMS)
• cardiovascular or musculoskeletal complications that preclude participation in intensive exercise
• Botulinum toxin (BTX-A) injections in the last 6 months
• Predicted GMFCS 4 or 5

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

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaynie Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Monica Gorassini, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

Pro00072587

Identifier Type: -

Identifier Source: org_study_id