Clinical Impacts of Structured Robotic Gait Training Programs

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Number of Sessions Attended — Approximately 8 weeks
  Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the number of sessions attended by the participants.
• Number of Sessions Missed — Approximately 8 weeks
  Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the number of sessions missed by the participants.
• Length of Session — Approximately 8 weeks
  Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the length of each training session.
• Number of steps per session — Approximately 8 weeks
  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.
• Clinician time per session — Approximately 8 weeks per participant enrolled.
  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

Trial sites (1)

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