Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia

Not Applicable

Completed

• Conditions: Spastic Diplegia
• Interventions: Behavioral: Intensive leg training with a physical therapist

• Registration Number: NCT03166293
• Lead Sponsor: University of Alberta

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-25
• Study Start: 2017-06-01
• Primary Completion: 2019-01-04
• Status Verified: 2020-11
• Study Completion: 2020-11-03
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delay Group	Intensive leg training with a physical therapist	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.
Immediate Group	Intensive leg training with a physical therapist	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.

Primary Outcome Measures

Name	Time	Method
Change in Gross Motor Functional Measure - 66 Items (GMFM-66) over 3 months	Baseline, 3 months	This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy.

Secondary Outcome Measures

Name	Time	Method
Change in forces during treadmill walking over 3 months	Baseline, 3 months	The child will be supported to walk on a treadmill while we record the leg motions and the forces under the feet during walking.

Trial Locations

Locations (2)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada