Ekoskeleton (Intervention): Exoskeleton walking three times per week for 12 weeks.
Relaxation (Comparator): Relaxation three times per week for 12 weeks.
Study summary
The goal of this feasibility trial is to learn if exoskeleton or robotic walking works to reduce nerve (neuropathic) pain after spinal cord injury.
This study asks is:
* Providing walking practice through use of a robotic device (exoskeleton) three times per week for twelve weeks possible to deliver?
* Would people sign up and stick to the programme?
* And will it help to reduce neuropathic pain levels after spinal injury?
Researchers will compare robotic walking and a relaxation program to see if robotic walking works to reduce neuropathic pain levels after spinal injury.
Participants will:
* Complete a number of questionnaires and tests related to their pain before the trial.
* Complete robotic walking or a relaxation program three times per week for twelve weeks.
* Complete the same questionnaires and tests after the trial finishes and 6 months after.
* Complete an interview telling researchers about their experiences of the trial.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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
Primary outcome measure(s)
International Spinal Cord Injury Pain Basic Data Set Version 3.0 (ISCIPBDS 3.0) (Pain intensity) — This will be measured at baseline, week 13 and at 6-month follow-up. This outcome measure will be used to capture average neuropathic pain intensity in participants
International Spinal Cord Injury Pain Basic Data Set Version 3.0 (ISCIPBDS 3.0) (Pain interference) — This will be measured at baseline, week 13 and at 6-month follow-up. This outcome measure will be used to capture average neuropathic pain interference in participants. Pain interference entails interference with sleep, daily activities and overall mood.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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