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Completed

NCT Number: NCT03166293

Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia

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.

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Key information

Age range

8 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive leg training with a physical therapist

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.

Other names: Therapist training

Primary outcomes

  1. Change in Gross Motor Functional Measure - 66 Items (GMFM-66) over 3 months

    Time frame: 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 outcomes

  1. Change in forces during treadmill walking over 3 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia From Encephalopathy of Prematurity

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 25, 2017
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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