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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Coma Recovery Scale-Revised (CRS-R) [Срок оценки: From enrollment to end of study at 2 weeks]

Вторичные конечные точки (9)

• Disability Rating Scale (DRS) [Срок оценки: Discharge from inpatient rehabilitation, an average of 8 weeks]
• CARE (Continuity Assessment Record and Evaluation) [Срок оценки: From inpatient admission through discharge from inpatient stay, assessed at routine intervals.]
• Electroencephalogram (EEG) [Срок оценки: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.]
• Event-Related Potential (ERP) - N100 [Срок оценки: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.]
• Event-Related Potential (ERP) - P300 [Срок оценки: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.]
• Event-Related Potential (ERP) - N400 [Срок оценки: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.]
• Rate of Adverse Events (AE) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Spaulding Rehabilitation Hospital — Boston

Идентификаторы

NCT: NCT07709559 · 2026P000662 · HT94252510986

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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