An observational study in Disorders of Consciousness Due to Severe Brain Injury and Disorders of Consciousness, sponsored by Spaulding Rehabilitation Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Spaulding Rehabilitation Hospital · Observational
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:
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:
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's planned enrollment of 18 is below the median of 79 across 95 observational studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Spaulding Rehabilitation Hospital is the lead sponsor of 117 studies on the registry; 27 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 17 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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.
Time frame: From enrollment to end of study at 2 weeks
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)
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
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)
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%).
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)
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.
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.
Start is estimated for Nov 2026; primary completion for Apr 2028, 17 months later.
Of 56 non-industry observational studies under Consciousness Disorders, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 95. This study's planned 17 months is below that.
Counting every sponsor, half of 58 studies reached it within 40 months; a quarter within 22 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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