ClinicalTrials.gg
RecruitingNCT06407219Updated Feb 6, 2026

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

An interventional study of Robot Assisted Gait Training in Physical Disability, CP (Cerebral Palsy) and Developmental Disability, sponsored by University of Calgary. Recruiting at 1 site in Canada. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by University of Calgary · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Mar 2022; still recruiting 4 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
4 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Cerebral Palsy by University of Calgary — 4 open to participants now, 4 under way, none of them phase 3. Cerebral Palsy · University of Calgary.

Planned enrollment
2nd of 10
50 · median 22
Started
2022
with 2 others
No phase
6 of 11
4 open now
Registered
6th of 11
by date

Among the 11 studies in Cerebral Palsy by University of Calgary, this one is the 2nd largest by planned enrollment of the 10 interventional ones, is one of 3 that started in 2022, is one of 6 with no phase, and was the 6th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

No phasethis study6 · 4 open
Phase 22 · 0 open
Observational1 · 0 open
Phase 11 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2010; this study’s year is marked. 3 started in 2022.

Size and results

Median enrollment 22 across the 10 interventional studies, 1 across the 1 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Cerebral Palsy by University of Calgary, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Physical Disability
  • CP (Cerebral Palsy)
  • Developmental Disability

Keywords

  • Robot Assisted Gait Training
  • Trexo
  • Rehabilitation
04

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • >150 lbs.
  • >5'6" tall
  • Medical to weight bearing (ie. recent orthopedic surgery)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceRobot 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.

06

What researchers measure

Primary outcomes

  1. Change in Heart Rate Response to Exercise

    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.

    Time frame: Through study completion, an average of 4 weeks.

Secondary outcomes

  1. Duration of Exercise Session

    Total time participant spends actively using the Trexo. This is measured directly using the Trexo Robotics application.

    Time frame: Through study completion, an average of 4 weeks.

  2. Total Number of Steps Taken

    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.

    Time frame: Through study completion, an average of 4 weeks.

  3. Average Number of Steps per Minute

    Average number of steps taken per minute while actively using the Trexo. This is measured directly in the Trexo Robotics application.

    Time frame: Through study completion, an average of 4 weeks.

  4. Participant or Proxy Report of Rating of Perceived Exertion (RPE)

    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).

    Time frame: Through study completion, an average of 4 weeks.

  5. Brain Region Activation

    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.

    Time frame: Through study completion, an average of 4 weeks.

  6. Muscle Activation

    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.

    Time frame: Through study completion, an average of 4 weeks.

  7. Characteristics of Gait / Walking Pattern

    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).

    Time frame: Through study completion, an average of 4 weeks.

  8. Leg Muscle Spasticity

    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.

    Time frame: Through study completion, an average of 4 weeks.

  9. Physical Activity Level

    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.

    Time frame: Through study completion, an average of 4 weeks.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06407219
Responsible party
Elizabeth Condliffe, PhD MD (Assistant Clinical Professor, University of Calgary) — Principal investigator
First posted
May 9, 2024
Start date
Mar 14, 2022
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Feb 6, 2026

Study contacts

PONI Lab
Contact
poni.lab@ucalgary.ca
4039555528
Benjamin M Norman, MSc
Contact
benjamin.norman@ucalgary.ca
4038301494
Elizabeth G Condliffe, MD, PhD
principal investigator · University of Calgary

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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