Initial Outcomes of Robotic Lower Extremity Exoskeleton Use by a Non-ambulatory Child With CP

Cerebral Palsy Clinical Trial

Official title:

Initial Outcomes of Robotic Lower Extremity Exoskeleton Use by a Non-ambulatory Child With Cerebral Palsy: A Case Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251390
• Other study ID #: REB19-1484
• Status: Completed
• Start date: December 6, 2019
• Est. completion date: February 4, 2021

Study information

• Verified date: February 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 4, 2021
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 7 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• trexo Home
12 week intervention, with weekly contact/assessments of the affects of using the trexo Home.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of bowel movements	Daily diary describing quantity and quality of bowel movements	Daily for 12 weeks
Primary	modified Ashworth Scale and modified Tardieu	Muscle spasticity measured in lower extremities	every 1-2 weeks for 12 weeks
Primary	Range of motion of lower extremities	Standardized goniometry to measure range of ankle, knee and hip joints	every 1-2 weeks over 12 weeks
Secondary	Early Clinical Assessment of Balance version 2	Measurement tool for postural balance and head control	every 1-2 weeks over 12 weeks
Secondary	Parent and caregiver anecdotal reports	To describe feasibility and tolerability of using the trexo at home or in the community	Weekly over 12 weeks
Secondary	Smiley face likert scale for Joy	A scale to quantify the participant's experience of joy while using the device	Daily when using the device over 12 weeks
Secondary	Portable Spasticity Assessment Device	A device and software system used to measure muscle spasticity	every 1-2 weeks over 12 weeks