Robot suit helps brain injury patients take steps in new study
NCT ID NCT07050875
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a robotic leg brace called the ABLE Exoskeleton in 14 people with acquired brain injury (including stroke). Participants used the device during 10 walking training sessions over up to 6 weeks. The main goals were to see if the device is safe and easy to use, and to gather early information on whether it can improve walking ability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ABLE Exoskeleton device
- What this could lead to
- If successful, this exoskeleton could help people with brain injury walk again during therapy, improving mobility and independence.
- What could go wrong
- This is a very small, early-stage study with only 14 participants and no comparison group. The device may not work for everyone or may be difficult to use.
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.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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14 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 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: * 18 to 80 years old * Diagnosed with acquired brain injury (ABI) * Currently undergoing outpatient physical therapy treatment in one of the investigation sites * Ability to give informed consent Exclusion Criteria: * Significant osteoporosis that may increase the risk of fracture * Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years * Spinal instability (or spinal orthoses, unless authorized by a physician) * Severe spasticity: Level 4 on the Modified Ashworth Scale * Orthostatic hypotension. Inability to tolerate a minimum of 10 minutes standing * Uncontrolled autonomic dysreflexia * Medical instability * Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP\>140, DBP\>90 mmHg), unresolved deep venous thrombosis (DVT), uncontrolled autonomic dysreflexia * Serious comorbidities, including any condition that a physician deems inappropriate for use of the ABLE Exoskeleton or to complete participation in the study * Skin integrity problems on the contact surfaces of the device or that would prevent sitting * Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton * Colostomy * Anthropometric measurements outside the values compatible with ABLE Exoskeleton. In particular, height not between 1.5-1.9 m, or weight over 100 kg * Anatomical constraints (such as leg length differences, users unable to position themselves inside the device) that are incompatible with the device * Restrictions in range of motion that prevent normal gait from being achieved or preventing the completion of a normal transition from sitting to standing or standing to sitting * Heterotopic ossification * Known pregnancy or breastfeeding * Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures * Requires assisted ventilation. * Scoliosis \>40-50º Cobb angle.
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Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
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Cefine Neurología (CEFINE)
Culleredo, A Coruña, 15174, Spain
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Centro Europeo de Neurociencias (CEN)
Madrid, Madrid, 28023, Spain
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Fundación Step by Step
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
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Other studies related to the condition(s) this trial covers.
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