Recruiting

Robotic Gait Trainer

Sponsor:

Children's Hospital of Eastern Ontario

Code:

NCT05378243

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 2 - 12

Healthy Volunteers: Not accepted

Interventions

Robotic Gait Training

Functional Clinical Therapy

Study Details

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

Conditions

Cerebral Palsy

Study ID

NCT05378243

Start date

Nov 8, 2021

Status verified date

Aug, 2023

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Mar 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 12

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Robotic Gait Training

8 weeks of therapy with the robotic gait training device 4-5 times a week for 1 hour each session

experimental: Functional Clinical Therapy

8 weeks of therapy with a custom designed therapy program for the participant's needs 4-5 times a week for 1 hour each session

Interventions

Robotic Gait Training

Use of a walker adapted with robotic components to promote proper walking gait

Functional Clinical Therapy

Personalized program of physical therapy targeted to improving walking gait

Primary outcome measure

  • Enrollment and recruitment in this study design [ Time Frame: 4 months ]
  • Retention in this study design [ Time Frame: 4 months ]
  • Adherance to protocol for each participant [ Time Frame: 4 months ]
  • Device tolerability [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Michelle Larin

6137377600MLarin@cheo.on.ca

Locations

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada

Contacts

Anna M McCormick, MD

613-737-7600amccormick@cheo.on.ca

Michelle Larin, MSc

613-737-7600MLarin@cheo.on.ca

Principal Investigator:

Anna M McCormick, MD

More Information

Sponsor

Children's Hospital of Eastern Ontario

Last update posted

Aug 29, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Eastern Ontario on 2023-08-29.