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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Robotic Gait Training; Behavioral: Functional Clinical Therapy

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) 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
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Larin; Phone Number: 4359 6137377600; Email: MLarin@cheo.on.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Recruiting
      • Children's Hospital of Eastern Ontario
      • Contact: Anna M McCormick, MD; Phone Number: 2831 613-737-7600; Email: amccormick@cheo.on.ca
      • Contact: Michelle Larin, MSc; Phone Number: 4359 613-737-7600; Email: MLarin@cheo.on.ca
      • Principal Investigator: Anna M McCormick, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Gait Training; 8 weeks of therapy with the robotic gait training device 4-5 times a week for 1 hour each session	Device: Robotic Gait Training; Use of a walker adapted with robotic components to promote proper walking gait
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	Behavioral: Functional Clinical Therapy; Personalized program of physical therapy targeted to improving walking gait

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
2 minute walk test (2mwt)	distance child is able to walk in their own walker in 2 minutes	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	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	4 months
Modified Ashworth Scale	The Modified Ashworth Scale measures resistance during passive soft tissue stretching. It is ranked by body part on a scale of 0-4 with 0 being a normal tone and 4 being highly rigid in flexion or extension.	4 months
Hypertonia Assessment Tool	Assessing dystonia, spasticity, and rigidity, or a mixed tone through a rating scale system where 0 indicates the behavior is not observed and 1 indicates the dystonic/spastic/rigid behavior is observed.	4 months
Barry Albright Dystonia Scale	Assessing dystonia and severity of dystonia in eyes, mouth, neck, trunk, each upper extremity and each lower extremity. Scored from 0-4 where 0 is an absence of dystonia and 4 is a high degree of dystonia.	4 months
Goal attainment scale	Attainment of self-determined goals for treatment outcomes. Goals are set with the study therapists at the outset of each treatment period and assessed using a scale of -2 to +2 where a score of 0 is the expected outcome, a negative score indicates less than expected and a positive number indicates more than expected	4 months
Spinal Alignment and Range of Motion Measure	Range of motion throughout the body is measured from 0-4 where 0 is no limitation and 4 is a severe limitation.	4 months
Leg Bone cortical density	peripheral Quantitative Computed Tomography (pQCT) Measures Cortical density (mg/cm2)	4 months
Tibia volumetric bone mineral density (BMD)	peripheral Quantitative Computed Tomography (pQCT) Measures Tibia volumetric bone mineral density (BMD) (mg/cm2)	4 months
Leg bone cortical cross-sectional area	peripheral Quantitative Computed Tomography (pQCT) Measures cortical cross-sectional area (mm2)	4 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Eastern Ontario
• Collaborators: Academic Health Science Centres; Ontario Brain Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 20200502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no intention to share IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No