Intensive leg exercise to improve walking in children with diplegia
Official title: Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia From Encephalopathy of Prematurity
Run by University of Alberta · NCT03672877 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study tests if intensive leg exercises can help young children with spastic diplegia walk better compared to regular physiotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Months to 36 Months |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT03672877 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with substantial upper extremity involvement, uncontrolled epilepsy, or recent botulinum toxin injections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with intensive therapy for children with similar conditions, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Effects of PNF and Task-Oriented Training on Upper-Limb Function in Children with Spastic Diplegic Cerebral Palsy
This study tests whether Proprioceptive Neuromuscular Facilitation (PNF), Task-Oriented Training (TOT), or both together can improve upper-extremity function in children with spastic diplegic cerebral palsy.
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Clemastine for Neonatal White Matter Injury
This small, early-stage study tests whether the drug clemastine is safe to give by mouth to premature babies with white matter injury and how the body handles the drug.
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Brain and spinal cord MRI changes in adults with cerebral palsy
We will look at past and new brain and spinal cord MRIs to see if adults with cerebral palsy develop brain or spinal cord atrophy over time.
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Training to improve muscle performance and coordination in children with spastic diplegia
This study is testing a new training program to see if it can help children with spastic diplegia improve their muscle strength and coordination better than regular physical therapy.
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Improving walking performance in children with cerebral palsy through a new therapy
This study is testing a new therapy to see if it can help children with cerebral palsy walk better by focusing on their personal walking goals with support from their caregivers.
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Dynamic movement intervention for children with spastic diplegia
This study is testing a movement program to see if it can help young children with spastic diplegia improve their balance and walking skills.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.