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

Children's Hospital of Eastern Ontario10 enrolled

Overview

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. The primary objective is to assess feasibility of the study design and device tolerability. Specifically: * Recruitment success (number screened, number eligible, number enrolled) where 80% of the recruitment target is reached. * Attrition rates of less than 10% (i.e. ≥90% of participant's successfully complete assessments). * Adherence for each participant: 80% of participants who complete assessments achieve the minimum target dose (i.e. approx. ≥30 hours of therapy in both study groups). * Qualitative feedback from clinicians and patients/caregivers on device tolerability and study participation. Secondary objectives will evaluate the distance a child can walk in two minutes using the Two Minute Walk Test (2MWT, 18) and will examine a more global impact of the use of this technology. Data collected will include quality of gait, child or proxy chosen individualized goals, hypertonicity, contractures, and bone health.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

Robotic Gait TrainingDEVICE

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

Functional Clinical TherapyBEHAVIORAL

Personalized program of physical therapy targeted to improving walking gait

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Enrollment and recruitment in this study design

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

Time frame: 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

Time frame: 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

Time frame: 4 months

Device tolerability

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

Time frame: 4 months

Secondary Outcomes

2 minute walk test (2mwt)

distance child is able to walk in their own walker in 2 minutes

Time frame: 4 months

Edinburgh Visual Gait Score

Edinburgh Visual Gait Score is used for assessing gait quality by assessing body positions and angles of various body parts through the gait pattern using a scale of 0-2 for each individual component of the assessment. A score of 0 indicates a more physiologically normal result while a score of 2 indicates a more disordered result. The scores are totaled to provide the complete score for the patient on this assessment

Time frame: 4 months

Physiological Cost Index

assessing gait efficiency by looking at the heart rate changes upon a specified exertional task. A lower physiological cost index indicates less exertion required to complete the task

Central Contacts

Michelle Larin

CONTACT

6137377600 MLarin@cheo.on.ca

Data from ClinicalTrials.gov

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