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.

NCT Number	NCT06780280
Lead Sponsor	Craig Hospital
Conditions	Traumatic Brain Injuries
Enrollment	25 participants
Start Date	2025-03-20
Primary Completion	2026-01-01 (estimated)
Study Completion	2026-01-30 (estimated)
Updated on ClinicalTrials.gov	2025-02-24