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

NCT04251390 | Completed

• 1 other identifier: REB19-1484
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

exoskeleton device

Outcome Measures

Primary Outcomes (3)

• Frequency of bowel movements

  Daily diary describing quantity and quality of bowel movements

  Daily for 12 weeks

• modified Ashworth Scale and modified Tardieu

  Muscle spasticity measured in lower extremities

  every 1-2 weeks for 12 weeks

• 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 Outcomes (4)

• Early Clinical Assessment of Balance version 2

  every 1-2 weeks over 12 weeks

• Parent and caregiver anecdotal reports

  Weekly over 12 weeks

• Smiley face likert scale for Joy

  Daily when using the device over 12 weeks

• Portable Spasticity Assessment Device

  every 1-2 weeks over 12 weeks

Study Arms (1)

trexo Home intervention

Participants family is renting a trexo Home from trexo. The decision to use the device was separate from this research, and the decision to do research on its use was secondary. The proposed procedures may be modified to adapt to the child and family's interest and needs. Participant will use the trexo Home in their home, school, and community.

Device: trexo Home

Interventions

trexo Home DEVICE

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

trexo Home intervention

Eligibility Criteria

• Age: 7 Years - 8 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

GMFCS IV

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Elizabeth G Condliffe, PhD, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 31, 2020
• Study Start: December 6, 2019
• Primary Completion: March 15, 2020
• Study Completion: February 4, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

CA (1)