NCT07405450 Clinical Impacts of Structured Robotic Gait Training Programs

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 120 participants in total. It began in 2022-11-01 with a primary completion date of 2026-05.

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.

Eligibility Criteria

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).

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