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

NCT06407219 | Recruiting

• 1 other identifier: REB21-1312
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Disability; CP (Cerebral Palsy); Developmental Disability

Keywords

Robot Assisted Gait Training; Trexo; Rehabilitation

Outcome Measures

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.

  Through study completion, an average of 4 weeks.

Secondary Outcomes (9)

• Duration of Exercise Session

  Through study completion, an average of 4 weeks.

• Total Number of Steps Taken

  Through study completion, an average of 4 weeks.

• Average Number of Steps per Minute

  Through study completion, an average of 4 weeks.

• Participant or Proxy Report of Rating of Perceived Exertion (RPE)

  Through study completion, an average of 4 weeks.

• Brain Region Activation

  Through study completion, an average of 4 weeks.

Study Arms (2)

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.

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

Device: Robot Assisted Gait Training

Interventions

Robot Assisted Gait Training DEVICE

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.

Passive "Endurance"; Voluntary activity "Strength"

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Developmental Disabilities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Elizabeth G Condliffe, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PONI Lab

CONTACT

4039555528; poni.lab@ucalgary.ca

Benjamin M Norman, MSc

CONTACT

4038301494; benjamin.norman@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which mode they are completing on which day. Caregivers may be told if they ask, and investigators and outcome investigators will know the randomization.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 9, 2024
• Study Start: March 14, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

CA (1)