Status:
UNKNOWN
Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV
Lead Sponsor:
Children's Hospital of Eastern Ontario
Collaborating Sponsors:
Ontario Brain Institute
Academic Health Science Centres
Conditions:
Cerebral Palsy
Eligibility:
All Genders
2-12 years
Phase:
NA
Brief Summary
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) g...
Detailed Description
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05378243
Start Date
November 8 2021
End Date
July 31 2024
Last Update
August 29 2023
Active Locations (1)
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1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada