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

NCT05378243 | Unknown

• 1 other identifier: 20200502
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Enrollment and recruitment in this study design

  Recruitment success as defined by meeting 80% of the recruitment target

  4 months

• Retention in this study design

  Attrition of less than 10% where 90% of participants are completing the assessments to the end of the trial

  4 months

• Adherance to protocol for each participant

  Participant self-reported session diaries will be assessed to determine whether participants are achieving the min target dose of 30h of therapy over each 8 week session

  4 months

• Device tolerability

  Participant caregivers will be interviewed for qualitative feedback on device/therapy tolerability after each 8 week session

  4 months

Secondary Outcomes (11)

• 2 minute walk test (2mwt)

  4 months

• Edinburgh Visual Gait Score

  4 months

• Physiological Cost Index

  4 months

• Modified Ashworth Scale

  4 months

• Hypertonia Assessment Tool

  4 months

Study Arms (2)

Robotic Gait Training

EXPERIMENTAL

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

Device: Robotic Gait Training

Functional Clinical Therapy

EXPERIMENTAL

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

Behavioral: Functional Clinical Therapy

Interventions

Robotic Gait Training DEVICE

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

Robotic Gait Training

Functional Clinical Therapy BEHAVIORAL

Personalized program of physical therapy targeted to improving walking gait

Functional Clinical Therapy

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• Ontario Brain Institute: collaborator
• Academic Health Science Centres: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Michelle Larin

CONTACT

6137377600; MLarin@cheo.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician / Physical Medicine and Rehabilitation Specialist, Division Chief Developmental Medicine and Rehabilitation

Model Details: Randomized crossover trial

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 18, 2022
• Study Start: November 8, 2021
• Primary Completion: March 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)