Using a robotic gait trainer to help children with cerebral palsy walk
Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV
This study is testing whether a robotic device can help children with cerebral palsy walk better compared to regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | Children's Hospital of Eastern Ontario Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05378243 on ClinicalTrials.gov |
What this trial studies
This study explores the effectiveness of a robotic gait training (RGT) device compared to functional clinical therapy (FCT) in children with cerebral palsy classified as GMFCS Levels III and IV. It employs a randomized, cross-over trial design where each child serves as their own control, allowing for a direct comparison of outcomes. The primary focus is on assessing the feasibility of the study design, device tolerability, and participant adherence, while secondary objectives include measuring walking distance and evaluating overall gait quality. The study aims to gather both quantitative and qualitative data to inform future interventions.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 12 years with cerebral palsy at GMFCS Levels III and IV who can take steps with or without assistance.
Not a fit: Patients who have had recent lower limb surgeries, botulinum toxin injections, or significant contractures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve walking abilities and overall mobility in children with cerebral palsy.
How similar studies have performed: Other studies have shown promise in using robotic devices for gait training in similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a diagnosis of cerebral palsy * GMFCS Levels III and IV * Ages ≥2 to ≤12 years * Ability to take steps with and/or without assistance * Meet the Trexo Plus device size requirements * Ability to follow instructions and signal pain, fear, or discomfort * Ability to safely use the device at home as determined by the study team Exclusion Criteria: * Lower limb or orthopedic surgery within 9 months prior to enrollment * Botulinum toxin injections within 4 months prior to enrollment * Serial casting within 3 months prior to enrollment * Knee flexion contracture \> 20° * Knee valgus \> 40° * Hip subluxation \> 40 % migration percentage * Uncontrolled movements that prevent transfer in and/or out of device * Weight bearing restrictions * Uncontrolled seizures * Skin lesions in areas where the device straps would be attached * Significant language barrier with parents and/or caregivers Note: children with severe contractures will be unable to fit in the device and are therefore excluded from the study
Where this trial is running
Ottawa, Ontario
- Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Michelle Larin
- Email: MLarin@cheo.on.ca
- Phone: 6137377600
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.