Walking With Overground Robotic Exoskeleton Device to Increase Behavioral Responsiveness in Patie… (NCT07709559) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Walking With Overground Robotic Exoskeleton Device to Increase Behavioral Responsiveness in Patients With Disorders of Consciousness (WALK DOC)
United States18 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 arthri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Coma Recovery Scale-Revised (CRS-R)
Timeframe: From enrollment to end of study at 2 weeks