Disorders of Consciousness Due to Severe Brain InjuryWALK DOCNCT07709559
Walking With Overground Robotic Exoskeleton Device to Increase Behavioral Responsiveness in Patients With Disorders of Consciousness (WALK DOC)
An observational study of Disorders of Consciousness Due to Severe Brain Injury and Disorders of Consciousness, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Disorders of Consciousness Due to Severe Brain Injury, Disorders of Consciousness
- What is being tested?
- Overground Robotic Exoskeleton (ORE)
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
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- 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).
- Uncontrolled diabetes.
- Infectious diseases or other serious complications.
- Uncorrectable leg length discrepancy over 2 cm when using additional correction tools.
- III-IV spine scoliotic deformity.
- Pregnant women should consult their physician prior to use.
- Amputations and lower limb prostheses.
- Morphological characteristics out of the device limitations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
Clinical Research Project Manager, 6179526354, jzhang71@mgb.org
Chad Swank, PhD
About this study
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:
Read more
- 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.
- Being tested
- Overground Robotic Exoskeleton (ORE)
- Keywords
- Overground Robotic Exoskeleton, Device Feasibility, Single Group
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Overground Robotic Exoskeleton (ORE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of study at 2 weeks
Secondary outcomes (9)
Disability Rating Scale (DRS)
The Disability Rating Scale (DRS) is an 8-item clinical tool used to track a patient's recovery from a moderate-to-severe traumatic brain injury (TBI) from the coma stage through to community living. Scores range from 0 (no disability) to 29 (extreme vegetative state)
Measured: Discharge from inpatient rehabilitation, an average of 8 weeks
CARE (Continuity Assessment Record and Evaluation)
The CARE (Continuity Assessment Record and Evaluation) tool is a standardized CMS assessment used to measure the medical, functional, cognitive, and social needs of Medicare post-acute care patients
The assessment evaluates four major domains:
- Medical Domain: Monitors changes in severity, active treatments, pain, and pressure ulcers.
- Functional Domain: Evaluates self-care and mobility prior to and during the illness (e.g., assessing mobility and daily living activities).
- Cognitive Domain: Assesses functional cognition, cognitive impairments, and factors affecting outcomes.
- Social/Environmental Factors: Reviews living situations, support systems, and discharge planning needs.
Measured: From inpatient admission through discharge from inpatient stay, assessed at routine intervals.
Electroencephalogram (EEG)
Cortical activity will be recorded continuously during the study sessions using a 24-channel mobile electroencephalography (EEG) system. Key positional changes will be marked in the EEG recording. EEG spectral power, including power within predefined brain wave frequency bands, will be evaluated before, during, and after positional changes. Changes in these measures will be used to evaluate cortical activity across study conditions. EEG frequency measures will be reported in hertz (Hz).
Measured: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
Event-Related Potential (ERP) - N100
Event-related potentials (ERP) will be recorded before and immediately after each study session. N100 ERP responses will be assessed, reflecting auditory sensory processing. For each response, the timing of the brain response (peak latency) will be measured. ERP latency measures will be reported in milliseconds (ms).
Measured: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
Event-Related Potential (ERP) - P300
Event-related potentials (ERP) will be recorded before and immediately after each study session. P300 ERP responses will be assessed, reflecting basic attention processing. For each response, the timing of the brain response (peak latency) will be measured. ERP latency measures will be reported in milliseconds (ms).
Measured: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
Event-Related Potential (ERP) - N400
Event-related potentials (ERP) will be recorded before and immediately after each study session. N400 ERP responses will be assessed, reflecting cognitive processing. For each response, the timing of the brain response (peak latency) will be measured. ERP latency measures will be reported in milliseconds (ms).
Measured: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
Rate of Adverse Events (AE)
Safety of the study will be measure via Rate of Adverse Events (AE). Reported exoskeleton-emergent AE will include: increase in pain behavior or agitation, disconcerting changes in cardiovascular function (e.g., sudden drop in blood pressure), skin irritation or orthopedic injuries caused by the robotic exoskeleton device, sudden changes in alertness (e.g., somnolence), autonomic storming, and seizure activity.
Measured: Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
Heart Rate Reserve (HRR)
Heart Rate Reserve (HRR) will be recorded as a measure of cardiovascular tolerability during the intervention. A heart rate monitor will be used to record the amount of time spent in each heart rate zone during ORE sessions: very light (<30% HRR), light (30-39%), moderate (40-59%), vigorous (60-89%), and near maximal (>90%).
Measured: Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
Session completion rate (SCR)
Session completion rate (SCR) will be used to assess the feasibility of completing the scheduled overground robotic exoskeleton sessions. Feasibility will be measured by the percentage of scheduled sessions that each participant completes. Based on prior clinical experience delivering exoskeleton sessions to patients with disorders of consciousness, successful session completion will be defined as completing at least 75% of the scheduled overground robotic exoskeleton sessions. For any missed session, the reason for the missed session and whether the session was rescheduled or made up will be documented. The time needed to complete any make-up sessions will also be recorded. These data will help determine whether the intervention schedule is practical and manageable for participants.
Measured: Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Consciousness Due to Severe Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chad, Swank, Spaulding Rehabilitation Hospital
- Investigators
- Chad Swank, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709559
- Sponsor's protocol ID
- 2026P000662
- Other IDs
- HT94252510986
- Acronym
- WALK DOC
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking With Overground Robotic Exoskeleton Device to Increase Behavioral Responsiveness in Patients With Disorders of Consciousness (WALK DOC)
- ClinicalTrials.gov ID
- NCT07709559
- Acronym / sponsor ID
- WALK DOC / 2026P000662
- Keywords
- Overground Robotic Exoskeleton, Device Feasibility, Single Group
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Disorders of Consciousness | – | Device: Overground Robotic Exoskeleton (ORE)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overground Robotic Exoskeleton (ORE)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. | Device | Patients with Disorders of Consciousness |
Primary outcome
Coma Recovery Scale-Revised (CRS-R)
Time frame: From enrollment to end of study at 2 weeks
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.
9 secondary outcomes
Disability Rating Scale (DRS)
Time frame: Discharge from inpatient rehabilitation, an average of 8 weeks
CARE (Continuity Assessment Record and Evaluation)
Time frame: From inpatient admission through discharge from inpatient stay, assessed at routine intervals.
Electroencephalogram (EEG)
Time frame: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
Event-Related Potential (ERP) - N100
Time frame: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
Event-Related Potential (ERP) - P300
Time frame: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
Event-Related Potential (ERP) - N400
Time frame: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
Rate of Adverse Events (AE)
Time frame: Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
Heart Rate Reserve (HRR)
Time frame: Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
Session completion rate (SCR)
Time frame: Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chad Swank, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Consciousness Due to Severe Brain Injury and Disorders of Consciousness, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Zhang, MS (6179526354, jzhang71@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale-Revised (CRS-R) (time frame: From enrollment to end of study at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.