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

Phase 2

Not yet recruiting

• Conditions: Traumatic Brain Injuries

• Registration Number: NCT06780280
• Lead Sponsor: Craig Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Study Start: 2025-03-20
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Individuals with DOC who are receiving inpatient rehabilitation

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse Events and feasibility	four weeks	We will measure all adverse advents.

Secondary Outcome Measures

Name	Time	Method
Coma Recovery Scale-Revised	four weeks	Measuring motor subscale, arrousal, and auditory subscales