Clinical Impacts of Structured Robotic Gait Training Programs

NCT07405450 | Recruiting

• 1 other identifier: REB22-0511
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Rationale: Walking impairments impacts the 2-3/1000 children who have cerebral palsy1,2, and others unable to walk due to other central nervous system disorders such as a traumatic brain injury. The impacts of this and related impairment impact all aspects of life. The lifelong costs of these is staggering in terms of dollars (over $1 million/child) and health adjusted life years (\~half compared to typically developing populations despite only slightly shorter lifespans). Yet there are currently no effective interventions to treat the fundamental balance impairment that underlie these problems4,5. Early use of robotic gait trainers have shown many benefits6,7, however access to these trainers is limited due to cost, availability, and ease of use within the home. Currently, there are a few options for an overground robotic gait trainer supported by the stability of a walker. The Trexo, is an option designed for use at home or in a community settings, but barriers to access mean that access to this therapy is out of reach for many people who may see benefits. Research Questions and Objectives: The aim of this study is to (a) evaluate the feasibility of a clinical robotic gait training program and (b) evaluate the effectiveness of these types of programs in achieving patient, family, and therapist goals. The study will examine adherence to a structured training program to determine if training with a robotic gait trainer in a hospital setting is feasible for the entire length of the designed training program. Goals will be set, a re-evaluation of these goals will be completed following the training program to determine whether or not the clinical program of robotic gait training was successful in helping patients reach the goals set out at the beginning of the program.

Conditions

Neuromotor Impairments; Walking Impairment

Keywords

Robotic Walking; Trexo

Outcome Measures

Primary Outcomes (5)

• Number of Sessions Attended

  Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the number of sessions attended by the participants.

  Approximately 8 weeks

• Number of Sessions Missed

  Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the number of sessions missed by the participants.

  Approximately 8 weeks

• Length of Session

  Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the length of each training session.

  Approximately 8 weeks

• Number of steps per session

  Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the number of steps taken by participants in each session.

  Approximately 8 weeks

• Clinician time per session

  Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the amount of time it takes clinicians to setup, run, and teardown for each training session

  Approximately 8 weeks per participant enrolled.

Secondary Outcomes (2)

• Canadian Occupational Performance Measure (COPM)

  Approximately 8 weeks

• Goal Attainment Scaling (GAS)

  Approximately 8 weeks

Study Arms (1)

Clinical Impacts of Structured Robotic Gait Training Programs

EXPERIMENTAL

All participants will participate in this arm involving 8 weeks of training 2-3 days/week

Device: Clinical Impacts of Structured Robotic Gait Training Programs

Interventions

Clinical Impacts of Structured Robotic Gait Training Programs DEVICE

All participants will participate in this arm involving 8 weeks of training 2-3 days/week using the Trexo walking device in clinic

Clinical Impacts of Structured Robotic Gait Training Programs

Eligibility Criteria

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

You may qualify if:

• able to fit into Trexo robotic gait trainer (both leg length and weight); height of \<\~5'6", weight \<150 lbs.)
• able to fulfill training requirements throughout training period
• able to comply with study procedures (assessments, training)
• any age

You may not qualify if:

• those with contraindications to training with a robotic gait trainer (ie. medical condition or recent surgery requiring lower extremity immobilization or weight-bearing restriction (ie. fracture, unstable hip subluxation), medical condition requiring a physical activity restriction (ie. unstable arrythmia), pain or symptomatic hypotension while standing, contracture such that the Trexo Robotic Gait Training does not result in forward movement)
• those involved in a potentially confounding intervention (will be discussed case-by-case to determine risk of impacting the study results).

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

Central Study Contacts

Christa Diot

CONTACT

403-955-5528; poni.lab@ucalgary.ca

Benjamin Norman

CONTACT

4038301494; benjamin.norman@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will complete robotic walking intervention only.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: February 12, 2026
• Study Start: November 1, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will become available at the end of the study. There is no plan to close the database.
• Access Criteria: Researchers requesting access to the database will be required to sign a Terms of Use agreement.

Locations

CA (1)