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

NCT06780280 | Not Yet Recruiting Phase 2

• 1 other identifier: CR-2874
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injuries

Keywords

TBI, disorders of consciousness, walking, exoskeletons

Outcome Measures

Primary Outcomes (1)

• Adverse Events and feasibility

  We will measure all adverse advents.

  four weeks

Secondary Outcomes (1)

• Coma Recovery Scale-Revised

  four weeks

Study Arms (1)

Walking Intervention

EXPERIMENTAL

Overground walking with an exoskeleton

Other: Overground Walking

Interventions

Overground Walking OTHER

Overground walking with an exoskeleton

Walking Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with DOC who are receiving inpatient rehabilitation

Sponsors & Collaborators

• Craig Hospital: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Candace Tefertiller, Executive Director of Research, PhD

CONTACT

3037898251; ctefertiller@craighospital.org

Clare Morey, MS

CONTACT

cmorey@craighospital.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: March 20, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 30, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share