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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Robotic Gait Training
* Behavioral: Functional Clinical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized crossover trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |