Evaluating the Impacts of a Single Session of Robot Assisted Gait Training With a Trexo

February 3, 2026 updated by: Elizabeth Condliffe, PhD MD, University of Calgary

Evaluating and Improving Robot Assisted Gait Training

Early use of robotic gait trainers have shown many benefits, however why these benefits occur and how to maximize them is unknown. There are a few options for how a robotic gait trainer can be used, however, there is not much understanding of how these options impact rehabilitation and compensate for impairments. The investigators aim to evaluate the impacts of as single session of Trexo robotic gait training and the impact of different modes of the Trexo robotic gait trainer. The investigators will evaluate how the different settings impact things like physical activity, walking, brain activity, spasticity, and fatigue. Investigators will arrange for a familiarity and fitting session to start, so that study team members can fit the participant to the Trexo and so that participants can become familiar with the feeling of using the Trexo robotic gait trainer. After the initial fitting sessions, follow up sessions will be completed to evaluate different settings on the Trexo, for example in "endurance" mode (where the robot completes the movements for the participant) and in "strength" mode (where the robot requires some assistance from the participant). Investigators may also test different fitting settings, for example with and without the supportive seat in the Trexo. Only three visits are required (one fitting/familiarity session and two testing sessions), however participants and/or their families may choose to complete more testing sessions if they want to assess other aspects of the training. For example, if the first two testing sessions assessed physical activity, participants and their families may choose to return for further sessions to assess brain activity. The aim of the study is to determine how robot assisted gait training impacts rehabilitation and compensates for impairments, as well as to provide suggestions on how the robotic gait trainer might be improved or modified. This study is exploratory to find out more about how these robotic gait trainers, specifically the Trexo, impacts various aspects of rehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital
        • Principal Investigator:
          • Elizabeth G Condliffe, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Able to fit into the Trexo robotic gait trainer (<150 lbs., <5'7").
  • Has impaired ability to walk due to a neurological or muscular disorder.

Exclusion Criteria:

  • >150 lbs.
  • >5'6" tall
  • Medical contraindication to weight bearing (ie. recent orthopedic surgery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Passive "Endurance"
Participants will complete a training session using the Trexo robotic gait trainer in the "endurance" mode with a fixed gait pattern regardless of the participant's activity.
Device: Robot Assisted Gait Training
The Trexo robotic gait trainer will be used to facilitate physical activity in people who cannot walk independently, either at all or without the use of assistive gait aids (ie. walkers or canes). Session length will be determined by the participant's perceived fatigue level (ie. the session will run until the participant feels they want to or need to stop), and will not exceed 1 hour of training time.
Active Comparator: Voluntary activity "Strength"
Participants will complete a training session using the Trexo robotic gait trainer in the "strength" mode where the gait pattern is impacted by the participant's activity
Device: Robot Assisted Gait Training
The Trexo robotic gait trainer will be used to facilitate physical activity in people who cannot walk independently, either at all or without the use of assistive gait aids (ie. walkers or canes). Session length will be determined by the participant's perceived fatigue level (ie. the session will run until the participant feels they want to or need to stop), and will not exceed 1 hour of training time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Response to Exercise
Time Frame: Through study completion, an average of 4 weeks.
We will use the collected heart rate as well as an estimated maximum heart rate (208-0.7*age) to determine the heart rate reserve (estimated maximum heart rate minus measured resting heart rate). Once the heart rate reserve has been calculated, the measured heart rate throughout the session will be used to determine how much time the participant spent above 40% of their heart rate reserve.
Through study completion, an average of 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Exercise Session
Time Frame: Through study completion, an average of 4 weeks.
Total time participant spends actively using the Trexo. This is measured directly using the Trexo Robotics application.
Through study completion, an average of 4 weeks.
Total Number of Steps Taken
Time Frame: Through study completion, an average of 4 weeks.
Total number of steps that the participant takes in the robotic gait trainer for the duration of the session. This is measured directly in the Trexo Robotics application.
Through study completion, an average of 4 weeks.
Average Number of Steps per Minute
Time Frame: Through study completion, an average of 4 weeks.
Average number of steps taken per minute while actively using the Trexo. This is measured directly in the Trexo Robotics application.
Through study completion, an average of 4 weeks.
Participant or Proxy Report of Rating of Perceived Exertion (RPE)
Time Frame: Through study completion, an average of 4 weeks.
The participant's (or proxy, if participant is unable to communicate their RPE) perceived level of exertion for the robot assisted gait training session. This will be assessed using a rating of fatigue scale (0-10).
Through study completion, an average of 4 weeks.
Brain Region Activation
Time Frame: Through study completion, an average of 4 weeks.
Brain region activation will be assessed using electroencephalography (EEG) or functional near infrared spectroscopy (fNIRS). Both methods require participants to wear a cap in order to record this data. There are no contraindications to EEG or fNIRS.
Through study completion, an average of 4 weeks.
Muscle Activation
Time Frame: Through study completion, an average of 4 weeks.
Muscle activation will be assessed using electromyography (EMG) or mechanomyography (MMG). Both methods require surface electrodes to be placed on the skin. There are no contraindications to EMG or MMG.
Through study completion, an average of 4 weeks.
Characteristics of Gait / Walking Pattern
Time Frame: Through study completion, an average of 4 weeks.
Assessed using inertial measurement units (IMUs) during training sessions as well as between sessions to gather data on gait patterns outside of the robotic gait trainer. IMUs will be placed on the top of each foot of the participant (2 IMUs total).
Through study completion, an average of 4 weeks.
Leg Muscle Spasticity
Time Frame: Through study completion, an average of 4 weeks.
Assessed using the EMG/MMG (mentioned above) and the Biodex dynamometer. Muscles to be assessed may include: quadriceps, hamstrings, and plantarflexors. The leg will be moved passively through its range of motion while muscle activation is sensed using the sensors of the EMG/MMG system.
Through study completion, an average of 4 weeks.
Physical Activity Level
Time Frame: Through study completion, an average of 4 weeks.
Reported physical activity levels will be assessed using the habitual activity estimation scale (HAES) for a typical weekday as well as a typical weekend day. The HAES is a participant or proxy report of physical activity levels.
Through study completion, an average of 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Elizabeth G Condliffe, MD, PhD, University Of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB21-1312

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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