Disorders of Consciousness, Disorders of Consciousness Due to Severe Brain Injury
Conditions
Keywords
Overground Robotic Exoskeleton, Device Feasibility, Single Group
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.
Interventions
DEVICEOverground 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.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coma Recovery Scale-Revised (CRS-R) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability Rating Scale (DRS) | Discharge from inpatient rehabilitation, an average of 8 weeks | 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) |
| CARE (Continuity Assessment Record and Evaluation) | From inpatient admission through discharge from inpatient stay, assessed at routine intervals. | 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. |
| Electroencephalogram (EEG) | Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation. | 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). |
| Event-Related Potential (ERP) - N100 | Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation. | 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). |
| Event-Related Potential (ERP) - P300 | Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation. | 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). |
| Event-Related Potential (ERP) - N400 | Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation. | 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). |
| Rate of Adverse Events (AE) | 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. | 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. |
| Heart Rate Reserve (HRR) | 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) 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%). |
| Session completion rate (SCR) | 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) 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. |
Countries
United States
Contacts
CONTACTJenny Zhang, MS
PRINCIPAL_INVESTIGATORChad Swank, PhD
Spaulding Rehabilitation Hospital
Outcome results
None listed