Walking With Overground Robotic Exoskeleton Device to Increase Behavioral Responsiveness in Patients With Disorders of Consciousness (WALK DOC)

NCT07709559 | Not Yet Recruiting FDA Device

• 2 other identifiers: 2026P000662HT94252510986
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn whether walking with an overground robotic exoskeleton (ORE) can improve responsiveness and brain activity in adults with disorders of consciousness (DoC) during inpatient rehabilitation after a severe brain injury. Participants include adults ages 18-70 who are in a coma, unresponsive wakefulness syndrome, or minimally conscious state and are receiving rehabilitation care at Spaulding Rehabilitation Hospital. The main questions it aims to answer are:

• Does using an ORE improve behavioral responsiveness compared with lying down, sitting, or standing?
• Does using an ORE increase brain activity, and are changes in brain activity related to changes in responsiveness?
• Is ORE therapy safe, tolerable, and feasible for people with DoC during inpatient rehabilitation? Researchers will compare participants' responses during sessions involving lying down, sitting, standing, and walking with the robotic exoskeleton to see if the exoskeleton leads to greater improvements in responsiveness and brain activity. Participants will:
• Complete an initial screening session to determine whether they can safely use the robotic exoskeleton.
• Participate in six study sessions over about two weeks during their rehabilitation stay. During these sessions, participants will complete activities that may include lying down, sitting, standing, and walking with a robotic exoskeleton. The order of activities will be assigned at random.
• Have their level of responsiveness measured before and after each session using a standardized assessment called the Coma Recovery Scale-Revised (CRS-R).
• Wear a wireless EEG cap before, during, and after sessions so researchers can measure brain activity.
• Have their heart rate and safety monitored throughout the study sessions.

Conditions

Disorders of Consciousness Due to Severe Brain Injury; Disorders of Consciousness

Keywords

Overground Robotic Exoskeleton; Device Feasibility; Single Group

Outcome Measures

Primary Outcomes (1)

• Coma Recovery Scale-Revised (CRS-R)

  The Coma Recovery Scale-Revised (CRS-R) is a 23-item behavioral assessment used to evaluate consciousness in patients with brain injuries. It measures auditory, visual, motor, oromotor, and communication functions. The total score ranges from a minimum of 0 to a maximum of 23, with higher scores indicating a higher level of neurobehavioral function and conscious awareness. CRS-R scores help characterize a patient's level of consciousness, including coma, vegetative state/unresponsive wakefulness syndrome, or minimally conscious state.

  From enrollment to end of study at 2 weeks

Secondary Outcomes (9)

• Disability Rating Scale (DRS)

  Discharge from inpatient rehabilitation, an average of 8 weeks

• CARE (Continuity Assessment Record and Evaluation)

  From inpatient admission through discharge from inpatient stay, assessed at routine intervals.

• Electroencephalogram (EEG)

  Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.

• Event-Related Potential (ERP) - N100

  Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.

• Event-Related Potential (ERP) - P300

  Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.

Study Arms (1)

Patients with Disorders of Consciousness

Adults with a disorder of consciousness, such as coma, unresponsive wakefulness syndrome, or a minimally conscious state, who are receiving inpatient rehabilitation after a severe brain injury.

Device: Overground Robotic Exoskeleton (ORE)

Interventions

Overground Robotic Exoskeleton (ORE) DEVICE

Participants will receive overground robotic exoskeleton-assisted standing and walking as part of inpatient rehabilitation. Following a screening session to assess device fit and tolerance, participants complete supervised ORE sessions. The intervention is distinguished by the use of assisted overground walking and upright mobility in individuals with disorders of consciousness and is evaluated in relation to behavioral responsiveness, brain activity, safety, tolerability, and feasibility.

Patients with Disorders of Consciousness

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from inpatient rehabilitation patients with disorders of consciousness (DoC) receiving medical care and rehabilitation at inpatient rehabilitation units in an inpatient rehabilitation facility (IRF) or long-term acute care hospital (LTAC). Patients will be identified from those admitted for inpatient rehabilitation and screened using the eligibility criteria outlined, through the hospital's standard clinical and medical record review processes.

You may qualify if:

• Medical diagnosis of disorders of consciousness (DoC) confirmed by the Coma Recovery Scale - Revised (CRS-R), including patient classified as Minimally Conscious State (MCS), Unresponsive Wakefulness Syndrome (UWS), or coma.
• Acute/Subacute phase of recovery
• Medically stable as deemed by a physician
• Undergoing medical care and rehabilitation at hospital
• Both sexes and all races and ethnicities
• Meet the robotic exoskeleton frame limitations
• Continence of or a program for bladder and bowel management

You may not qualify if:

• Concurrent spinal cord injury (SCI)
• Degenerative diagnoses, pre-morbid developmental disability, significant psychological diagnosis such as bipolar disorder and schizophrenia
• Any contraindication to use the exoskeleton device, including:
• Contracture in the hip, knee and ankle joints.
• Uncorrectable Equinovarus foot deformation.
• Severe muscular spasticity of the lower extremities (Modified Ashworth Scale Grade 3 higher).
• Fractures or incomplete bone junctions in the spine, pelvis, and/or lower extremities.
• Osteoporosis or lower bone mineral density -3.5, and history(ies) of osteoporotic fracture(s).
• Skin disorders including Stage I pressure injuries at the hip, lower limbs, and Exoskeleton contact areas, according to the National and European Pressure Ulcer Classification System (NPUAP-EPUAP).
• Inability to communicate with an Assistant due to cognitive and language disorders.
• Severe arthritis, acute arthritis, or synovitis after total or partial lower limb joint replacement.
• Orthostatic hypotension, essential hypertension, and a condition in which blood pressure is not controlled.
• Myocardial infarction or angina or ischemic heart disease within the last 6 months.
• Tachycardia, bradycardia, arrhythmia and other cardiac functions that are not controlled.
• Uncontrolled autonomic dysreflexia (AD).

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chad Swank, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Zhang, MS

CONTACT

6179526354; jzhang71@mgb.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, Associate Professor

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

US (1)