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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251390
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Elizabeth Condliffe, University of Calgary

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.

Condition or disease Intervention/treatment
Cerebral Palsy Device: trexo Home

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Initial Outcomes of Robotic Lower Extremity Exoskeleton Use by a Non-ambulatory Child With Cerebral Palsy: A Case Study
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Frequency of bowel movements [ Time Frame: Daily for 12 weeks ]
    Daily diary describing quantity and quality of bowel movements

  2. modified Ashworth Scale and modified Tardieu [ Time Frame: every 1-2 weeks for 12 weeks ]
    Muscle spasticity measured in lower extremities

  3. Range of motion of lower extremities [ Time Frame: every 1-2 weeks over 12 weeks ]
    Standardized goniometry to measure range of ankle, knee and hip joints


Secondary Outcome Measures :
  1. Early Clinical Assessment of Balance version 2 [ Time Frame: every 1-2 weeks over 12 weeks ]
    Measurement tool for postural balance and head control

  2. Parent and caregiver anecdotal reports [ Time Frame: Weekly over 12 weeks ]
    To describe feasibility and tolerability of using the trexo at home or in the community

  3. Smiley face likert scale for Joy [ Time Frame: Daily when using the device over 12 weeks ]
    A scale to quantify the participant's experience of joy while using the device

  4. Portable Spasticity Assessment Device [ Time Frame: every 1-2 weeks over 12 weeks ]
    A device and software system used to measure muscle spasticity



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 8 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
GMFCS IV
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251390


Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Elizabeth G Condliffe, PhD, MD University of Calgary
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Responsible Party: Elizabeth Condliffe, Assistant Clinical Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT04251390    
Other Study ID Numbers: REB19-1484
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Condliffe, University of Calgary:
exoskeleton device
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases