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

NCT06780280 · Craig Hospital · Updated 24 Feb 2025

What is being tested
Overground Walking
For
Traumatic Brain Injuries
Kind of study
Tests a treatment or device on volunteers. Phase 2 and Phase 3.
Who can join
Ages 18 years and older. About 25 people. The full rules are on the registry page.
Where
Not stated
When
Starts or started 20 March 2025, ends 30 Jan 2026. Registered 17 Jan 2025.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT06780280