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

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

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06780280
Acronym
ORE-DOC
Enrollment
25
Registered
2025-01-17
Start date
2025-03-20
Completion date
2026-01-30
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injuries

Keywords

TBI, disorders of consciousness, walking, exoskeletons

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.

Interventions

Overground walking with an exoskeleton

Sponsors

Craig Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Individuals with DOC who are receiving inpatient rehabilitation

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Adverse Events and feasibilityfour weeksWe will measure all adverse advents.

Secondary

MeasureTime frameDescription
Coma Recovery Scale-Revisedfour weeksMeasuring motor subscale, arrousal, and auditory subscales

Contacts

Primary ContactCandace Tefertiller, Executive Director of Research, PhD
ctefertiller@craighospital.org3037898251
Backup ContactClare Morey, MS
cmorey@craighospital.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026