Clinical trial NCT04251390: Initial Outcomes of Robotic Lower Extremity Exoskeleton Use by a Non-ambulatory Child With CP
Official title: Initial Outcomes of Robotic Lower Extremity Exoskeleton Use by a Non-ambulatory Child With Cerebral Palsy: A Case Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: exoskeleton device
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 1
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GMFCS IV

Brief summary: There are very few evidence-based interventions for children with cerebral palsy who cannot walk. The Trexo-Home is a device that is newly available for rent by families, but its impact is unknown. By tracking and recording various outcome measures throughout this project, the investigators hope to inform future larger scale controlled studies.

Detailed description: Design: This is a prospective case study to understand how a walking-aid device (Trexo-Home) that has been rented by a family, may impact a child with cerebral palsy (CP) who cannot walk. The decision to use the device was separate from this research, and the decision to do research on it's use was secondary, making it an observational study. The proposed procedures below may be modified to adapt to the child and family's interest and needs.

Background and Rationale: Evidence suggests that positive health outcomes are associated with reducing sedentary behaviour and sitting time. For individuals with significant motor impairments, spending the majority of their days sitting in a wheelchair is often a reality, potentially leading to secondary preventable chronic diseases such as type 2 diabetes, cardiovascular disease, and some cancers. Many children with CP have mobility limitations, and approximately 30% are non-ambulatory or require assistive devices. Currently, there are very few treatments available for non-ambulatory children with CP, and treatments may be invasive or have undesirable side effects. Tréxō Robotics (Trexo) aims to bridge the gap in treatments available for non-ambulatory children. Trexo offers a robotic exoskeleton that enables children to walk using a gait trainer with an external power source with the safety of a walker. This revolutionary technology is new to the world of pediatric rehabilitation, and Trexo Home provides the advantage of versatility to use the device at home or in the community on a daily basis. This means children who would otherwise spend most of their day sitting in a wheelchair can now stand and walk on a daily basis using this device in a familiar setting. Presently, the impacts of its use are unknown, however similar exoskeletons used with adults with spinal cord injury (SCI) show promising health benefits beyond enjoyment of walking again, such as improvements in spasticity and regularity of bowel movements.

This case study will involve one 7 year old child with CP who is functionally non-ambulatory. This child's family holds an agreement to lease the Trexo Home for a period of 6 months. Through the exploratory nature and prospective design of this case study, the investigators will gather critical data for informing future larger scale, controlled studies. With limited pediatric data related to the use of robotic assisted movement, this information could potentially add to or alter current interventions recommended for children with significant motor impairments.

Objective: The objective of this case study is to thoroughly assess the impact of Trexo Home use in one 7 year old child with CP (Gross Motor Function Classification System level IV).

i) Does using a robotic exoskeleton meet the family's primary goal - facilitating their child's experience of joy? ii) What is the family's experience around feasibility and the child's tolerability of using the Trexo at home or in the community? iii) What are the initial physiologic outcomes following twelve weeks of Trexo use?

Methods: Implementation of this project will occur over 16 weeks, with a baseline period of 4 weeks , an intervention period of 12 weeks. Throughout the project the investigators will have weekly contact with the participant's family. This frequency was selected in discussion with the family.

Joy will be evaluated using a Smiley Face Likert Scale, completed separately by the child and the parents on a weekly basis.

Feasibility and Tolerability will be quantified by number of minutes of Trexo Home use and number of steps taken per day. Reasons for skipping or abbreviating a therapeutic session will be recorded.

Physiologic outcomes evaluate key symptoms of cerebral palsy and secondary complications.

Spasticity will be assessed every second week using clinical measures (modified Tardieu and modified Ashworth Scale) and quantitative measures (the Portable Spasticity Assessment Device which differentiates reflexive and intrinsic stiffness).

Range of motion (ROM) at the hip and knee joint bilaterally will be measured via standardized goniometry, and will be done every second week, on alternate weeks from the spasticity assessment.

The child's sitting balance will be assessed monthly using the Early Clinical Assessment of Balance Version 2.

Bowel movement frequency and any related medication use will be tracked with daily diaries. This area has significant potential to enhance the quality of life of an individual, and adults with a spinal cord injury using exoskeleton have noted benefits.

Videos of the balance assessment and of free movement will occur in phase 1 and every month during phase 2, the intervention period. Video of the child using the Trexo device will be taken every two weeks in phase 2.

Eligibility criteria: Inclusion Criteria:

* This case study will involve one 7 year old child with cerebral palsy who is functionally non-ambulatory. This is a prospective case study to understand how a walking-aid device (trexo Home) that has been rented by a family, may impact a child with cerebral palsy who cannot walk. The decision to use the trexo exoskeleton device was separate from this research, and the decision to do research on its use was secondary.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Frequency of bowel movements
timeFrame: Daily for 12 weeks
measure: modified Ashworth Scale and modified Tardieu
timeFrame: every 1-2 weeks for 12 weeks
measure: Range of motion of lower extremities
timeFrame: every 1-2 weeks over 12 weeks
Secondary outcomes:
measure: Early Clinical Assessment of Balance version 2
timeFrame: every 1-2 weeks over 12 weeks
measure: Parent and caregiver anecdotal reports
timeFrame: Weekly over 12 weeks
measure: Smiley face likert scale for Joy
timeFrame: Daily when using the device over 12 weeks
measure: Portable Spasticity Assessment Device
timeFrame: every 1-2 weeks over 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Elizabeth G Condliffe, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: