Physical DisabilityNCT06407219
Evaluating the Impacts of a Single Session of Robot Assisted Gait Training With a Trexo
A study testing Robot Assisted Gait Training in people with Physical Disability and CP (Cerebral Palsy), run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Physical Disability, CP (Cerebral Palsy), Developmental Disability
- What is being tested?
- Robot Assisted Gait Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- >150 lbs.
- >5'6" tall
- Medical contraindication to weight bearing (ie. recent orthopedic surgery)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Benjamin M Norman, MSc, 4038301494, benjamin.norman@ucalgary.ca
Elizabeth G Condliffe, MD, PhD
About this study
Official title: 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.
- Being tested
- Robot Assisted Gait Training
- Keywords
- Robot Assisted Gait Training, Trexo, Rehabilitation
- Medical subject headings
- Cerebral Palsy, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Assisted Gait TrainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Passive "Endurance" | Active comparator | 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. Receives: Device: Robot Assisted Gait Training |
| Voluntary activity "Strength" | Active comparator | 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 Receives: Device: Robot Assisted Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 4 weeks.
Secondary outcomes (9)
Duration of Exercise Session
Total time participant spends actively using the Trexo. This is measured directly using the Trexo Robotics application.
Measured: Through study completion, an average of 4 weeks.
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.
Measured: Through study completion, an average of 4 weeks.
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.
Measured: Through study completion, an average of 4 weeks.
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).
Measured: Through study completion, an average of 4 weeks.
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.
Measured: Through study completion, an average of 4 weeks.
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.
Measured: Through study completion, an average of 4 weeks.
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).
Measured: Through study completion, an average of 4 weeks.
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.
Measured: Through study completion, an average of 4 weeks.
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.
Measured: Through study completion, an average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start14 Mar 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a randomized cross-over design, where participants will complete a training session in both the endurance mode and the strength mode of the Trexo robotic gait trainer. The session completed first will be randomized.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Condliffe, PhD MD, University of Calgary
- Investigators
- Elizabeth G Condliffe, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407219
- Sponsor's protocol ID
- REB21-1312
- Status last verified
- Feb 2026
- First submitted
- 14 Apr 2022
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating and Improving Robot Assisted Gait Training
- ClinicalTrials.gov ID
- NCT06407219
- Acronym / sponsor ID
- REB21-1312
- Keywords
- Robot Assisted Gait Training, Trexo, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a randomized cross-over design, where participants will complete a training session in both the endurance mode and the strength mode of the Trexo robotic gait trainer. The session completed first will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Passive "Endurance" | Active comparator | Device: Robot Assisted Gait TrainingParticipants 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. |
| Voluntary activity "Strength" | Active comparator | Device: Robot Assisted Gait TrainingParticipants 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 |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- >150 lbs.
- >5'6" tall
- Medical contraindication to weight bearing (ie. recent orthopedic surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot Assisted Gait TrainingThe 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. | Device | Passive "Endurance", Voluntary activity "Strength" |
Primary outcome
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.
9 secondary outcomes
Duration of Exercise Session
Time frame: Through study completion, an average of 4 weeks.
Total Number of Steps Taken
Time frame: Through study completion, an average of 4 weeks.
Average Number of Steps per Minute
Time frame: 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.
Brain Region Activation
Time frame: Through study completion, an average of 4 weeks.
Muscle Activation
Time frame: Through study completion, an average of 4 weeks.
Characteristics of Gait / Walking Pattern
Time frame: Through study completion, an average of 4 weeks.
Leg Muscle Spasticity
Time frame: Through study completion, an average of 4 weeks.
Physical Activity Level
Time frame: Through study completion, an average of 4 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth G Condliffe, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Assisted Gait Training in people with Physical Disability and CP (Cerebral Palsy), run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PONI Lab (4039555528, poni.lab@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate Response to Exercise (time frame: Through study completion, an average of 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.