WALK DOC: Robotic Exoskeleton for Disorders of Consciousness

This observational study, called WALK DOC, is looking at whether using an Overground Robotic Exoskeleton (ORE) can help adults with disorders of consciousness (DoC) become more responsive. DoC includes conditions like coma, unresponsive wakefulness syndrome, or a minimally conscious state, often after a severe brain injury. You might be eligible if you are 18-70 years old, medically stable, and receiving inpatient rehabilitation at Spaulding Rehabilitation Hospital. The study aims to see if walking with the ORE improves your responsiveness and brain activity compared to lying, sitting, or standing. Success will be measured by changes in your Coma Recovery Scale-Revised (CRS-R) score over two weeks. The study is currently recruiting 18 participants.

Study design
This is an observational study involving 18 participants. It aims to see if using an Overground Robotic Exoskeleton (ORE) can improve responsiveness in patients with disorders of consciousness.
What's involved
You would participate in supervised ORE sessions as part of your inpatient rehabilitation. This includes a screening session to ensure the device fits and you can tolerate it.
Compensation
Not stated in the trial record.
Follow-up
Your responsiveness will be measured using the Coma Recovery Scale-Revised (CRS-R) from enrollment until the end of the study at 2 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07709559

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

Not Yet Recruiting
Not specifiedAges 18–70Observational
Spaulding Rehabilitation Hospital
~18 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Overground Robotic Exoskeleton (ORE)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Coma Recovery Scale-Revised (CRS-R)
Measured over From enrollment to end of study at 2 weeks
Disorders of Consciousness Due to Severe Brain Injury
Disorders of Consciousness

NCT07709559

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Spaulding Rehabilitation Hospital

    Boston, Massachusettsstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Chad Swank, PhD · PRINCIPAL_INVESTIGATOR · Spaulding Rehabilitation Hospital

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Eligibility criteria

Inclusion

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

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.
  • 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.