Recruiting

Robotic Gait Training

Sponsor:

University of Calgary

Code:

NCT07405450

Conditions

Neuromotor Impairments

Walking Impairment

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Clinical Impacts of Structured Robotic Gait Training Programs

Study Details

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

Study ID

NCT07405450

Start date

Nov 1, 2022

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Clinical Impacts of Structured Robotic Gait Training Programs

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

Interventions

Clinical Impacts of Structured Robotic Gait Training Programs

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

Primary outcome measure

  • Number of Sessions Attended [ Time Frame: Approximately 8 weeks ]
  • Number of Sessions Missed [ Time Frame: Approximately 8 weeks ]
  • Length of Session [ Time Frame: Approximately 8 weeks ]
  • Number of steps per session [ Time Frame: Approximately 8 weeks ]
  • Clinician time per session [ Time Frame: Approximately 8 weeks per participant enrolled. ]

Central Contacts and Locations

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

More Information

Sponsor

University of Calgary

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Robotic Walking
  • Trexo

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-02-12.