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

Launched by UNIVERSITY OF ALBERTA · Sep 13, 2018

Keywords

ClinConnect Summary

This clinical trial is studying whether a special program of intensive leg exercises can help improve walking in young children who have spastic diplegia, a condition that affects movement in both legs. The trial compares this exercise program to standard physiotherapy care over three months to see which approach works better for helping children move more easily.

To be eligible for this trial, children should be between 2 to 3 years old and have some difficulty using their legs but can stand with some support. They should also have experienced a specific type of brain injury related to being born prematurely. However, children with serious problems using their arms or those who have had certain medical issues recently may not be able to participate. If a child joins the trial, they will be part of a group that either does the intensive exercises or receives standard care, and both groups will be monitored to see how their walking improves. This trial aims to provide valuable information that could help many children with similar conditions in the future.

Gender

ALL

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