Robot suit could revolutionize walking recovery for spinal cord patients
NCT ID NCT07036107
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a wearable robotic exoskeleton helps people with recent spinal cord injury regain walking ability better than standard physical therapy. Eighty participants will be randomly assigned to either robot-assisted or conventional gait training for 8 weeks. Researchers will also measure if the robot reduces caregiver burden and healthcare costs.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- 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 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: * diagnosis of spinal cord injury (SCI) in the acute or subacute phase (\< 6 months of evolution) * traumatic or non-traumatic aetiology * neurological level of the SCI between C5 and L5 for patients with American Spinal Injury Association Impairment Scale (AIS) C or D, and SCI between C7 and L5 for patients with AIS A or B. * sufficient strength in the upper extremities to handle a walker (triceps muscle score ≥ 4 according to the Medical Research Council (MRC) scale). * range of motion (ROM) without limitations in the lower extremities (achieve at least a knee extension of 10 degrees and neutral ankle position) * muscle spasticity in the lower extremities with a score ≤ 3 on the Modified Ashworth Scale (MAS) * tolerate bipedalism (having stood up in the last year) * aged between 18 and 70 years, with height between 150 cm and 190 cm, and weight less than 100 kg Exclusion Criteria: * WISCI ≥ 15 * cognitive or neurological limitations that prevent following instructions * another neurologic disorder permanently affecting gait and gait therapy (other than SCI) * grade I or higher in the European Pressure Ulcer Advisory Panel (EPUAP) in the areas of contact with the exoskeleton * unresolved fractures at the time of the study * uncontrolled autonomic dysautonomia * intolerance to exercise * uncontrolled epilepsy * previous experience with Robotic-Assisted Gait Training (RAGT). * ROM restriction such as flexing or arthrodesis will be excluded * spinal instability (or spinal orthotics unless cleared by a medical doctor). * deterioration \>3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and/or motor activity above the level of injury detected that has not been evaluated by a doctor.
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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.
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
2 sites. 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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Hospital Nacional de Parapléjicos
NOT_YET_RECRUITINGToledo, Castille-La Mancha, 45071, Spain
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Hospital Universitario de Vall d'Hebron
RECRUITINGBarcelona, Catalonia, 08035, Spain
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