Clinical trial NCT05473676: Robotic Walking for Children Who Cannot Walk
Official title: Robotic Walking for Children Who Cannot Walk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Mobility Limitation
Brain Injuries
Spinal Cord Injuries
Spina Bifida
Keywords: Robot Assisted Gait Training
Trexo
Rehabilitation
Robotic Training
Assisted Walking
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 19
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will proceed through the same study timeline from the time of enrollment.
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Training Time
timeFrame: Assessed throughout the 12 weeks (Week 5 through Week 16) robotic training period.
measure: Training Frequency
timeFrame: Assessed throughout the 12 week (Week 5 through Week 16) robotic training period.
measure: Canadian Occupational Performance Measures (COPM)
timeFrame: 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).
measure: Goal Attainment Scaling
timeFrame: 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).
measure: Early Clinical Assessment of Balance (ECAB)
timeFrame: Assessed monthly from time of enrollment through 3-months post-training.
Secondary outcomes:
measure: Number of Participants Enrolled and Completed
timeFrame: Assessed throughout the study duration, an average of 7-9 months depending on time of enrollment..
measure: Caregiver Priorities & Child Health Index of Life with Disabilities (CP-CHILD)
timeFrame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
measure: EQ-5D-Y (Youth)
timeFrame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
measure: CarerQOL
timeFrame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
measure: Focus Groups
timeFrame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
measure: Head Control While Walking
timeFrame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28)..
measure: Seated Limits of Stability
timeFrame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
measure: Ramp & Hold
timeFrame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
measure: Voluntary Muscle Activity
timeFrame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
measure: Modified Tardieu Scale
timeFrame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
measure: Habitual Activity Estimation Scale (HAES)
timeFrame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
measure: PROMIS Sleep Disturbance Questionnaire
timeFrame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
measure: Heart Rate Reserve
timeFrame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
measure: Distance Walked
timeFrame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
measure: Sleep Duration
timeFrame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
measure: Bowel Function
timeFrame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Pediatric Onset of Neuromotor Impairments Lab, Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Elizabeth G Condliffe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: