Robot Assisted Gait Training for Physical Disabilities

Overseen By Benjamin M Norman, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Over 150 lbs, Over 5'6", Medical contraindication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a robotic device called the Trexo aids individuals with physical disabilities in improving their walking. The researchers aim to assess how different settings on the Trexo, such as "strength" mode, where users assist with movement, and "endurance" mode, where the robot performs most of the work, affect recovery and activity levels. The trial seeks participants who have difficulty walking due to neurological or muscular issues and meet size requirements (under 150 lbs and 5'7"). It involves three sessions to test these modes and their impact on physical activity and fatigue. This research aims to determine the optimal use of the Trexo in rehabilitation. As an unphased trial, it offers participants the chance to contribute to pioneering research that could enhance rehabilitation techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this robotic gait trainer is safe for rehabilitation?

Research has shown that the Trexo robotic gait trainer is generally safe and well-received. Studies examining its use at home and in communities have not identified any major safety issues. Users often report positive outcomes, such as taking more steps during sessions.

Another study assessed the ease and practicality of using Trexo and checked for any unwanted side effects, finding no significant problems. This suggests that Trexo is safe for participants.

Overall, the Trexo robotic gait trainer appears to be a safe choice for those considering joining a trial with this device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of Trexo robotic gait training for physical disabilities because it offers a unique approach to rehabilitation. Unlike traditional physical therapy, which often relies on manual assistance or simple exercise machines, Trexo uses advanced robotics to adapt to the user's needs. In the "strength" mode, the robot adjusts its gait pattern based on the participant's activity, potentially enhancing muscle engagement and recovery. Meanwhile, the "endurance" mode provides a consistent gait pattern, which might improve stamina and walking duration. This adaptive technology could offer personalized rehabilitation, making it a promising option for those with physical disabilities.

What evidence suggests that the Trexo robotic gait trainer is effective for physical disabilities?

Research has shown that using the Trexo device for robotic walking exercises can address other health issues in individuals with severe brain and nerve problems. In this trial, participants will use the Trexo in two modes: "strength" mode, where the participant's activity affects the gait pattern, and "endurance" mode, which has a fixed gait pattern. Studies suggest that by facilitating repeated walking, the Trexo can enhance endurance, core strength, and balance. Regular users of the Trexo have reported improvements, such as better walking ability and increased activity levels. Personal stories also highlight benefits in exercise frequency and consistency. These findings support the idea that the Trexo aids rehabilitation by boosting physical activity and overcoming physical challenges. ^{1 2 3 4 5}

Who Is on the Research Team?

Elizabeth G Condliffe, MD, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for individuals with physical disabilities, including cerebral palsy and developmental disabilities. Participants will be fitted to a Trexo robotic gait trainer and must be comfortable using it. The study requires three visits but offers additional sessions if desired.

Inclusion Criteria

Has impaired ability to walk due to a neurological or muscular disorder.

Able to fit into the Trexo robotic gait trainer (<150 lbs., <5'7").

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Fitting and Familiarization

Participants undergo a fitting session to become familiar with the Trexo robotic gait trainer

1 session

1 visit (in-person)

Testing

Participants complete testing sessions using the Trexo in different modes to evaluate impacts on physical activity, walking, brain activity, spasticity, and fatigue

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Trexo

Trial Overview

The study tests the effects of a single session of robot-assisted gait training using the Trexo device in different modes: 'endurance' where the robot does more work, and 'strength' where participants contribute more effort. It explores how these settings affect rehabilitation outcomes.

How Is the Trial Designed?

Group I: Voluntary activity "Strength" Active Control 1 Intervention

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

Group II: Passive "Endurance" Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10047646/

Robot-Assisted Gait Training with Trexo Home - PMC - NIH

Robotic gait training has the potential to improve secondary health conditions for people with severe neurological impairment.

2.

trexorobotics.com

trexorobotics.com/pt-tool-for-mobility-challenges/

Trexo Overview for Clinics & PTs

Endurance & Strength Building: By facilitating repetitive walking, Trexo helps build endurance, core strength, and postural control. • Motor ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07405450

Clinical Impacts of Structured Robotic Gait Training Programs

Outcome measures will include feasibility of training, usability of the Trexo as a training device, assessment of goals, and adverse events.

4.

researchgate.net

researchgate.net/publication/368804449_Robot-Assisted_Gait_Training_with_Trexo_Home_Users_Usage_and_Initial_Impacts

(PDF) Robot-Assisted Gait Training with Trexo Home

Conclusions: Data and anecdotal reports suggest that regular use of the Trexo Home robotic gait trainer has positive outcomes on frequency and ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714423000095

Contemporary Clinical Trials

A randomized, cross-over trial comparing the effect of innovative robotic gait training and functional clinical therapy in children with cerebral palsy.