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

NCT ID: NCT06780280

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-01-30

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.

Conditions

Traumatic Brain Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Walking Intervention

Overground walking with an exoskeleton

Group Type: EXPERIMENTAL

Overground Walking

Intervention Type: OTHER

Overground walking with an exoskeleton

Interventions

Overground Walking

Overground walking with an exoskeleton

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals with DOC who are receiving inpatient rehabilitation

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Candace Tefertiller, Executive Director of Research, PhD

Role: CONTACT

ctefertiller@craighospital.org

3037898251

Clare Morey, MS

Role: CONTACT

cmorey@craighospital.org

Other Identifiers

CR-2874

Identifier Type: -

Identifier Source: org_study_id