Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP)

NCT06463418 | Active Not Recruiting DMC

• 1 other identifier: DIFA-2023-008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Spinal Cord Injury

Keywords

Spinal Cord Injuries; Robotics; Pain; Neurorehabilitation; Adult; Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• International Spinal Cord Injury Pain Basic Data Set Version 3.0 (ISCIPBDS 3.0) (Pain intensity)

  This outcome measure will be used to capture average neuropathic pain intensity in participants

  This will be measured at baseline, week 13 and at 6-month follow-up.

• International Spinal Cord Injury Pain Basic Data Set Version 3.0 (ISCIPBDS 3.0) (Pain interference)

  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 will be measured at baseline, week 13 and at 6-month follow-up.

Secondary Outcomes (2)

• Neuropathic Pain Symptom Inventory (NPSI)

  This will be measured at baseline, week 13 and at 6-month follow-up.

• Electroencephelography (EEG)

  This will be measured at baseline, week 13 and at 6-month follow-up.

Study Arms (2)

Exoskeleton (Intervention)

EXPERIMENTAL

Exoskeleton walking delivered three times per week for twelve weeks. Each session will be one hour duration.

Device: Ekoskeleton (Intervention)

Relaxation (Comparator)

ACTIVE COMPARATOR

An equally dosed blended relaxation program delivered online for two sessions per week and in-person one session per week.

Other: Relaxation (Comparator)

Interventions

Ekoskeleton (Intervention) DEVICE

Exoskeleton walking three times per week for 12 weeks.

Also known as: Ekso NR

Exoskeleton (Intervention)

Relaxation (Comparator) OTHER

Relaxation three times per week for 12 weeks.

Relaxation (Comparator)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• Royal College of Surgeons, Ireland: collaborator
• University of Aarhus: collaborator

Study Sites (1)

University College Dublin

Dublin, Ireland

Location

Related Publications (43)

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  BACKGROUND

• IBM Corp. Released 2023. IBM SPSS Statistics for Windows, Version 29.0.2.0 Armonk, NY: IBM Corp

  BACKGROUND

• White C, Doherty O, Smith E, Blake C, Finnerup NB, Kirwan N, Pollock M, Lennon O. Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial. HRB Open Res. 2024 Sep 2;7:55. doi: 10.12688/hrbopenres.13949.1. eCollection 2024.

  PMID: 39840276 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Pain; Neuralgia

Interventions

Methods

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Olive Lennon, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 17, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 year after the end of the project. Anonymised data will be available indefinitely on Zenodo with a DOI under a CC0 license.
• Access Criteria: Researchers who are affiliated with a university or research centre. They must provide a rationale for how the study data are relevant to a related study question around spinal cord injury pain. They must have documented training in research integrity. Requests will be reviewed by the study PI and study steering committee prior to granting access.

Locations

IE (1)