Robot walks could ease nerve pain in spinal injury patients
NCT ID NCT06463418
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether walking with a robotic exoskeleton three times a week for 12 weeks can reduce nerve pain in people with spinal cord injury. Forty adults with traumatic spinal injury and persistent nerve pain will be randomly assigned to either robotic walking or a relaxation program. Researchers will measure pain levels, sleep, mood, and daily activities before, after, and 6 months later, and also interview participants about their experience.
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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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Nov 2026
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.
- Ages
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18 to 90 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Individuals who are 18 years and over. * Confirmed traumatic SCI (injury resulted from an external physical impact and not an acute or chronic disease process) of \>6 months duration with complete or incomplete paraplegia or tetraplegia. * Individuals with above confirmed traumatic SCI who have below-level NP (≥ 3 levels below neurological level and/or extending to at-level region) starting after the SCI and persisting for \> 3 continuous months, despite pharmacotherapy. * NP will be confirmed based on a neurological examination, a score of ≥4 on the Douleur Neuropathique 4 (DN4) (48) and a comprehensive pain history supported by the use of the ISCIP Pain Classification. They endorse one or more of the following pain descriptors to assist in confirmation of below level NP "'hot-burning', 'tingling', 'pricking', 'pins and needles', 'sharp', 'shooting', 'squeezing', 'painful cold' and 'electric shock-like'" (45). * Moderate and severe NP as confirmed above will be described as pain ≥ 3 and ≥ 6 on the 0-10 Numerical Rating Scale (NRS) for NP (averaged over a week). * Exoskeleton naive * Stable medication regimen * Have the capacity to provide informed consent. Exclusion Criteria: * Non-traumatic SCI, cauda equina lesions or Guillain Barré diagnoses * NP intensities of \<3 (NRS) or nociceptive pain profiles only based on the ISCIP pain classification convention. * Recent lower limb fracture * Inadequate bone density (z score \< -2) * Anthropometric measurements incompatible with the exoskeleton device (i.e. height \>1.9m, weight \>100kgs, significant lower limb spasticity) * Unstable comorbid medical condition/psychiatric condition/medication regimen * Planned surgery coinciding with intervention * Pregnancy * Drug and alcohol abuse
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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.
Contacts and locations
Locations
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University College Dublin
Dublin, Ireland
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Other studies related to the condition(s) this trial covers.
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