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NCT Number: NCT06780280

Walking With Overground Robotic Exoskeletons to Improve Arrousal in Individuals With Disorders of Consciousness

This proposed study will examine a walking intervention to promote changes in conscious state in individuals with disorders of consciousness (DoC) due to acquired brain injury (ABI). Recent practice guidelines highlight the need to develop interventions to arouse patients with DoC, as current treatment options are scarce with limited to low-quality pharmaceutical and electrical stimulation approaches to improve outcomes. New data indicates patients with chronic DoC may benefit from therapeutic intervention prioritizing repeated multimodal sensory (i.e., simultaneous vestibular, proprioceptive, and visual) input, but likely not attain comparable functional recovery to those who demonstrate early command following ability. Interventions activating pathways of the cerebral consciousness network may leverage a substrate for recovery. We hypothesize that walking in an overground robotic exoskeleton (ORE) is safe, feasible, and will simultaneously stimulate endogenous cognitive and automatic pathways associated with walking5 to promote changes in behavioral performance in individuals with DoC.

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Key information

About this study

The objective of this study is to evaluate the safety, feasibility and tolerability of using ORE therapy with individuals who meet criteria for DoC during inpatient rehabilitation while evaluating changes in behavioral performance, neurophysiology, and physiologic response to training. DoC numbers are very small so our goal is to gather this pilot data to support a future multi-site efficacy study with other TBIMS Center partners.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with DOC who are receiving inpatient rehabilitation

Exclusion criteria

-

Treatment and study plan

Overground Walking

Other

Overground walking with an exoskeleton

Primary outcomes

  1. Adverse Events and feasibility

    Time frame: four weeks

    We will measure all adverse advents.

Secondary outcomes

  1. Coma Recovery Scale-Revised

    Time frame: four weeks

    Measuring motor subscale, arrousal, and auditory subscales

Study contacts

Contact information is provided by the study sponsor or research team.

Candace Tefertiller, Executive Director of Research, PhD

CONTACT

[email protected]

3037898251

Clare Morey, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Registry information

Acronym: ORE-DOC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 17, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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