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Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV

Cerebral Palsy

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) group, and functional clinical therapy (FCT) using each subject as their own control.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    2 to 12

Participation 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

Study Location

Children's Hospital of Eastern Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Anna M McCormick, MD

[email protected]
613-737-7600
Backup Contact

Michelle Larin, MSc

[email protected]
613-737-7600
Study Sponsored By
Children's Hospital of Eastern Ontario
Participants Required
More Information
Study ID: NCT05378243