Robotic Walking for Children Who Cannot Walk

Study Overview
=================
Brief Summary
-----------------
A common problem among children with nervous system disorders is difficulty walking on their own. This has impacts beyond mobility including short and long-term health conditions associated with physical inactivity and different developmental experiences as a result of the mobility impairments. A robotic trainer can both provide rehabilitation and be an assistive device to help compensate for difficulties. Figuring out how to prescribe it is critical to improve daily life for children with significant disabilities. Preliminary use of robotic trainers have shown many benefits, such as better head control and improved independence in transfers, which greatly increases ability to live independently. Additionally, vital functions that are frequently impaired in those with less physical activity, such as sleep and bowel habits, seem to improve. Finally, these children enjoy using them. This project aims to determine who is most likely to benefit from training with a robotic trainer and investigate key details about the dose of training that is needed. Families that are already using or hope to use robotic training need this data to help improve their access to the intervention. Clinicians need this systematic approach to building evidence to ensure a future multi-centre randomized control trial is well designed. This study is needed to help improve the lives of those who live with significant disabilities. The objective is to evaluate the feasibility and impacts of delivering robotic gait training at home. Integral in this study is capturing the user perspectives. This will both provide preliminary evidence-based advice to potential users, their families, and clinicians as well as provide key metrics to design a definitive multi-centre randomized control trial. The investigators will provide robotic gait trainers, specifically Trexo robotic gait trainers, to participants and their families to use in their home communities for 12 weeks to evaluate the feasibility and impacts of intensive robotic gait training in people who cannot walk independently. Assessments will be completed throughout the duration of study, including before, during, and after the training intervention, with the goal of evaluating a wide range of feasibility considerations and impacts from robotic training.

Official Title
-----------------
Robotic Walking for Children Who Cannot Walk

Conditions
-----------------
Cerebral Palsy, Mobility Limitation, Brain Injuries, Spinal Cord Injuries, Spina Bifida

Intervention / Treatment
-----------------
* Device: Robotic Training Period


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 4 years of age Unable to walk independently due to pediatric onset, non-progressive central nervous system disorder or injury (ie. cerebral palsy or acquired brain injury) Able to fit into Trexo robotic gait trainer (both leg length and weight) Able to fulfill training requirements throughout training period (5 days/week for at least 30 minutes each session) Able to comply with study procedures (assessments, training) Exclusion Criteria: Medical condition or recent surgery requiring lower extremity immobilization or weight-bearing restrictions (ie. fracture, unstable hip subluxation). Medical condition requiring a physical activity restriction (ie. unstable arrhythmia). Pain or symptomatic hypotension while standing. Contracture such that the Trexo robotic gait trainer does not result in forward movement. Current involvement in a potentially confounding intervention (determined on a case-by-case basis).

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will proceed through the same study timeline from the time of enrollment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Training Period<br>Participants will engage in robot assisted gait training on at least 5 days/week for at least 30 minutes each day, for a total period of 12 weeks. | Device: Robotic Training Period<br>* Participants will engage in robot assisted gait training on at least 5 days/week for at least 30 minutes each day, for a total period of 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training Time | Time spent in the trainer each session, total time spent in the trainer (weekly, monthly). | Assessed throughout the 12 weeks (Week 5 through Week 16) robotic training period. | 
| Training Frequency | Frequency of training sessions (days/week). | Assessed throughout the 12 week (Week 5 through Week 16) robotic training period. | 
| Canadian Occupational Performance Measures (COPM) | Structured questions and rating scales to determine problem areas and goals for training. Identified problems are scored on a 10 point scale, 1 being not able to complete the task at all. | Assessed at enrollment (Week 0), before Robotic Gait Training period ( Week 4), following Robotic Gait Training period ( Week 16), and at 3-months post-training ( Week 28). | 
| Goal Attainment Scaling | Rating of success in achieving an outcome or desired goal (identified using the COPM), where 0 = the expected level of achievement, -2 = much less achieved than expected, and +2 = much more achieved than expected. | Assessed at enrollment (Week 0), before Robotic Gait Training period ( Week 4), following Robotic Gait Training period ( Week 16), and at 3-months post-training ( Week 28). | 
| Early Clinical Assessment of Balance (ECAB) | Clinical balance assessment to determine participant's balance capabilities. | Assessed monthly from time of enrollment through 3-months post-training. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Enrolled and Completed | Assessment of number of participants that start the study and how many are able to complete the study. | Assessed throughout the study duration, an average of 7-9 months depending on time of enrollment.. | 
| Caregiver Priorities & Child Health Index of Life with Disabilities (CP-CHILD) | Qualitative assessment of impacts of robotic gait training on participants and families. | Assessed before ( Week 4) and after ( Week 16) robotic gait training. | 
| EQ-5D-Y (Youth) | Qualitative assessment of impacts of robotic gait training on participants and families. | Assessed before ( Week 4) and after ( Week 16) robotic gait training. | 
| CarerQOL | Qualitative assessment of impacts of robotic gait training on participants and families. | Assessed before ( Week 4) and after ( Week 16) robotic gait training. | 
| Focus Groups | Semi-structured interviews with participants and families and/or caregivers. Themes will include independence in daily function and feedback on training with the device. | Assessed before ( Week 4) and after ( Week 16) robotic gait training. | 
| Head Control While Walking | Head angle from vertical will be measured to determine if head control is impacted by training. | Assessed at enrollment (Week 0), before Robotic Training Period ( Week 4), after Robotic Training Period ( Week 16), and 3-months post-training ( Week 28).. | 
| Seated Limits of Stability | Forward, backward, and side to side leaning will be assessed to evaluate trunk strength and control. | Assessed at enrollment (Week 0), before Robotic Training Period ( Week 4), after Robotic Training Period ( Week 16), and 3-months post-training ( Week 28). | 
| Ramp & Hold | Evaluation of stiffness and involuntary muscle activity, recorded using electromyography (EMG) or mechanomyography (MMG). | Assessed at enrollment (Week 0), before Robotic Training Period ( Week 4), after Robotic Training Period ( Week 16), and 3-months post-training ( Week 28). | 
| Voluntary Muscle Activity | Evaluation of voluntary muscle contractions. Recorded using EMG or MMG. | Assessed at enrollment (Week 0), before Robotic Training Period ( Week 4), after Robotic Training Period ( Week 16), and 3-months post-training ( Week 28). | 
| Modified Tardieu Scale | Clinician movement of joint to determine range of motion and angle of catch at the joint. Joint neutral is defined as 0 degrees, where any range beyond neutral is recorded in + degrees and any range not reaching neutral is recorded in - degrees. | Assessed monthly from time of enrollment (Week 0) through to 3-months post-training ( Week 28). | 
| Habitual Activity Estimation Scale (HAES) | Participant or proxy report of estimated physical activity during a typical weekday and week-end day. Participants or proxy report a percentage of time spent inactive, somewhat inactive, somewhat active, and active on a typical weekday and week-end day. | Assessed monthly from time of enrollment (Week 0) through to 3-months post-training ( Week 28). | 
| PROMIS Sleep Disturbance Questionnaire | Participant or proxy report of sleep disturbances. Participants or a proxy will rate different sleep scenarios on a 5 point scale, 1 being Never and 5 being Always. | Assessed monthly from time of enrollment (Week 0) through to 3-months post-training ( Week 28). | 
| Heart Rate Reserve | Week-long assessment measuring heart rate, tracked using Actigraph wearable sensor worn on chest and wrist. | Assessed continually for 1 week at Week 0,  Week 4,  Week 5-8 (once),  Week 12-16 (once),  Week 17, and  Week 28 | 
| Distance Walked | Week-long assessment measuring heart rate, tracked using inertial measurement units (IMUs) worn on feet. | Assessed continually for 1 week at Week 0,  Week 4,  Week 5-8 (once),  Week 12-16 (once),  Week 17, and  Week 28 | 
| Sleep Duration | Week-long assessment measuring heart rate, tracked using Actigraph wearable sensor worn on chest and wrist. | Assessed continually for 1 week at Week 0,  Week 4,  Week 5-8 (once),  Week 12-16 (once),  Week 17, and  Week 28 | 
| Bowel Function | Week-long assessment measuring frequency and quality of bowel movements as well as any interventions used to facilitate bowel movements, for example medications. Tracked using participant or proxy reports in a daily diary provided by study team. | Assessed continually for 1 week at Week 0,  Week 4,  Week 5-8 (once),  Week 12-16 (once),  Week 17, and  Week 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robot Assisted Gait Training, Trexo, Rehabilitation, Robotic Training, Assisted Walking