Robotic Training Period for Brain Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pediatric Onset of Neuromotor Impairments Lab, Alberta Children's Hospital, Calgary, Canada
Brain Injuries+6 More
Robotic Training Period - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Brain Injuries
  • Cerebral Palsy
  • Mobility Limitation
  • Spina Bifida
  • Spinal Cord Injuries

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 16 Secondary · Reporting Duration: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).

Week 28
Canadian Occupational Performance Measures (COPM)
Goal Attainment Scaling
Week 28
Ramp & Hold
Seated Limits of Stability
Voluntary Muscle Activity
Week 28
Head Control While Walking
Week 16
Caregiver Priorities & Child Health Index of Life with Disabilities (CP-CHILD)
CarerQOL
EQ-5D-Y (Youth)
Focus Groups
Week 28
Bowel Function
Distance Walked
Heart Rate Reserve
Sleep Duration
Week 28
Habitual Activity Estimation Scale (HAES)
Modified Tardieu Scale
PROMIS Sleep Disturbance Questionnaire
Assessed monthly from time of enrollment through 3-months post-training.
Early Clinical Assessment of Balance (ECAB)
Week 16
Training Frequency
Week 16
Training Time
Month 9
Number of Participants Enrolled and Completed

Trial Safety

Trial Design

1 Treatment Group

Robotic Training Period
1 of 1
Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Robotic Training Period · No Placebo Group · N/A

Robotic Training Period
Device
Experimental Group · 1 Intervention: Robotic Training Period · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at enrollment (week 0), before robotic training period (~week 4), after robotic training period (~week 16), and 3-months post-training (~week 28).

Trial Background

Prof. Elizabeth Condliffe, MD PhD
Principal Investigator
University of Calgary
Closest Location: Pediatric Onset of Neuromotor Impairments Lab, Alberta Children's Hospital · Calgary, Canada
Photo of Calgary  1Photo of Calgary  2Photo of Calgary  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Brain Injuries
0 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 4 years old.
You are able to fulfill training requirements throughout training period (5 days/week for at least 30 minutes each session).
You are able to comply with study procedures (assessments, training).
You are unable to walk independently due to pediatric onset, non-progressive central nervous system disorder or injury (ie.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.