Robotic walking suit may awaken the brain after severe injury
NCT ID NCT07709559
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study explores whether walking with an overground robotic exoskeleton can increase behavioral responsiveness and brain activity in adults with disorders of consciousness after a severe brain injury. Participants, aged 18 to 70 and in a coma, unresponsive wakefulness syndrome, or minimally conscious state, will complete six sessions over two weeks that may include lying down, sitting, standing, and walking with the device. Researchers will measure responsiveness using the Coma Recovery Scale-Revised and brain activity with EEG to see if upright walking offers unique benefits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- overground robotic exoskeleton (ORE) device
- What this could lead to
- If walking with a robotic exoskeleton boosts responsiveness, it could point toward a new therapy to help people with disorders of consciousness regain awareness.
- What could go wrong
- This is a very small, early-stage study with only 18 participants, so results may not apply to everyone. The intervention is also complex and may not be safe or tolerable for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129, United States
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