Intensive leg exercise to improve walking in children with diplegia
Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia From Encephalopathy of Prematurity
This study tests if intensive leg exercises can help young children with spastic diplegia walk better compared to regular physiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 8 Months to 36 Months |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT03672877 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares three months of intensive leg exercise to standard physiotherapy in young children with spastic diplegia. It aims to improve gross motor function by providing active physical therapy, which is typically infrequent in current treatment approaches. Children aged 8 months to 3 years will be randomly assigned to either immediate treatment or a delay group, allowing researchers to assess the effectiveness of early intervention. The study will measure various outcomes, including motor development and walking proficiency, and will follow participants until they are four years old to evaluate long-term benefits.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 months to 3 years with bilateral motor impairment of the lower extremities due to periventricular white matter injury.
Not a fit: Patients with substantial upper extremity involvement, uncontrolled epilepsy, or recent botulinum toxin injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance walking abilities and overall motor function in children with spastic diplegia.
How similar studies have performed: Previous studies have shown promising results with intensive therapy for children with similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta and 1 other locations
- Alberta Children's Hospital — Calgary, Alberta, Canada (Recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Jaynie Yang, Phd — Universtiy of Alberta
- Study coordinator: Donna Livingstone, BScPT
- Email: carre@ualberta.ca
- Phone: 780-492-4858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.