An interventional study of Ekoskeleton (Intervention) and Relaxation (Comparator) in Traumatic Spinal Cord Injury, sponsored by University College Dublin. Active, not recruiting at 1 site in Ireland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University College Dublin · Not applicable, Interventional, and Treatment
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:
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:
Background and Rationale:
Following SCI, approximately 53% of people develop neuropathic pain (NP). Irish SCI data identifies high pain intensity and pain interference levels with NP and significantly poorer quality of life (QoL) than other pain phenotypes. Individuals can describe NP as more debilitating than the other consequences of SCI, as their most persistent health issue and adequate pain relief as an unmet need.
International data identify the proportional burden of NP following SCI as significant. Ninety-four percent of individuals are prescribed >1 medication, the mean number of physician office visits in a 6-month period due to SCI NP is reported as 2 and the total annualised cost of NP per subject in the United States (US) is reported as $26,270 (direct $8,636, indirect $17,634).
The presence of pain is further associated with lower return to work rates following injury, and more than a third of individuals with SCI in employment report frequent pain interference with their work . Pain interference with function, health status and work are noted to be significantly worse in individuals with more severe NP, where overall work impairment is reported at 38%.
NP after SCI is multi-faceted and heterogenous, making isolation of specific mechanisms more challenging. Mechanisms hypothesised for NP after SCI include neuronal hyperexcitability (central and peripheral sensitisation) and corticothalamic maladaptive neuroplasticity. Additionally, NP symptom severity post SCI has been reported to be associated with a combination of residual spinothalamic tract (STT) function below the level of injury and with catastrophising pain coping mechanisms.
The mechanistic effects of sensorimotor stimulation on NP stem from Phantom Limb Pain research (PLP) with significant reversal of cortical dysfunction in the primary somatosensory cortex of individuals with PLP evident. Similar maladaptive cortical reorganisation is hypothesised to be associated with NP in SCI.
This is further supported by data garnered from electroencephalography (EEG) studies showing that changes in oscillatory brain activity known as thalamo-cortical dysrhythmia, are associated with the presence of NP. NP in SCI is associated with an EEG power signal increase in the theta band and possibly high beta band but a decrease in the high-alpha-low-beta band. In addition, NP in SCI is associated with decreased reactivity of alpha band power signals in response to eye opening. Thus it has applications as a biomarker for current NP and as a predictor of development of future NP.
The mainstay of NP treatment after SCI is pharmacotherapy with anticonvulsants and antidepressants to reduce pain intensity. Pregabalin/gabapentin, duloxetine, amitriptyline and/or opioids are the first- and second-line treatments recommended, although severe pain remains refractory to these treatments in 2⁄3 of sufferers. Survey data report high use of non-steroidal anti-inflammatories and paracetamol.
Significant side-effects of medications are reported. SCI patients are particularly prone to central nervous system related side effects which are often intolerable. These, together with fear of medication dependency, result in poor adherence to pharmacological regimens leading to a call for non-pharmacological treatment options for people with NP after SCI.
Virtual reality (immersive virtual walking virtual illusion/imagined walking) has shown promise for reducing NP intensity and interference after SCI. Virtual illusion interventions show evidence of direct and corrective stimulation to the reorganised sensorimotor areas in SCI patients with NP, supporting the theory that NP mechanisms are reversible. However, actual sensorimotor intervention studies are inconclusive in SCI at this point with limited focus on walking despite compelling preclinical studies showing prevention and/or reversal of SCI neuropathic pain. Notably in animal studies, other exercise paradigms including swimming and stance training had only transient or no effects on SCI-induced NP suggesting that the rhythmic stimulation of proprioceptive and mechanosensory afferents together with weight bearing experienced in walking might be necessary to reduce NP.
The exoskeleton intervention itself is not new within the neurorehabilitation space for SCI. However, no RCTs to date have specifically recruited participants with moderate-to-severe NP in order to assess its mechanistic effects on NP. The ExSCIP randomised feasibility trial addresses this current knowledge gap, examining exoskeleton-based walking 3 times per week, as a mechanistic-based intervention for NP after SCI. It will test the feasibility and acceptability of an exoskeleton, and whether it demonstrates positive signals in reduction of NP intensity and interference levels to warrant onward progression to a definitive trial.
Aims and Objectives:
The overall aim of this study is to examine the feasibility and acceptability of an exoskeleton, mechanistic-targeted, walking intervention for NP in people with SCI.
The primary objectives for the study are:
The ExSCIP study is a phase 2 randomised, single blinded, feasibility trial with the aim of examining progression criteria for a definitive trial.
Progression criteria are based on consideration of the primary objectives around feasibility and the potential for effectiveness and implementation in clinical practice. Quantitative and qualitative process evaluation data will be analysed to consider the following continuation criteria.
Participant Screening:
Stage 1: Phone Screening:
NP will be screened for as a minimum criterion initially by phone. This phone screening will do the following:
Stage 2: In-Person Assessment:
An in-person assessment to confirm participant suitability will be performed by an independent assessor. The assessment will entail the following steps:
Confirmation of presence of moderate to severe below level NP:
Anthropometric and clinical assessment for compatibility for use of exoskeleton:
- Participants will undergo an anthropometric assessment to ensure no height, weight, joint range of movement or muscle spasticity restrictions to exoskeleton use apply.
Stage 3: Informed consent and data collection:
Data/statistical analysis:
Descriptive statistics and estimation using 95% CIs will be the main focus of the analysis. The number of participants recruited and retained, and information on missing or incomplete data from all outcome measures will be explored. Baseline demographics and outcome variables will be compared at all assessment times within groups.
For categorical measures, frequencies and percentages will be presented and for continuous measures, the mean and standard deviation (SD) will be reported. For continuous measures which show evidence of some skew a median and interquartile range may also be presented or substituted for the mean and SD. Within group change scores and their 95% CI will be examined in relation to the MCID. Repeated measures ANOVAs will be used to compare between group differences of continuous variables across the three time points. Statistical significance will be determined α-priori at an alpha level of 0.05.
For analysis of EEG data, this will be an exploratory analysis using a multilevel linear mixed model (LMM) approach to examine differences between the intervention groups over time in the EEG alpha, beta and theta band power. Repeated measures within participants will be modelled as a random effect. Fixed effects in the model, will include group assignment and time. The moderating effects of pain intensity and interference will also be evaluated. The LMM will study both main effects and interaction effects using the R package lme4 to fit the models. Models will be compared using Likelihood Ratio Tests (LRT) to assess the significance of effects. Statistical significance will be determined α-priori at an alpha level of 0.05.
When all data is collected, data analysis will be conducted by a data processor blinded to group allocation. A full statistical analysis plan will be prepared prior to final analysis. Statistical analysis will be conducted using SPSS version 29 software and analysis will be conducted as intention to treat (ITT) and per protocol.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 40 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University College Dublin is the lead sponsor of 108 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exoskeleton walking delivered three times per week for twelve weeks. Each session will be one hour duration.
Device: Ekoskeleton (Intervention)
An equally dosed blended relaxation program delivered online for two sessions per week and in-person one session per week.
Other: Relaxation (Comparator)
Exoskeleton walking three times per week for 12 weeks.
Also known as: Ekso NR
Relaxation three times per week for 12 weeks.
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
Time frame: 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.
Time frame: This will be measured at baseline, week 13 and at 6-month follow-up.
Neuropathic Pain Symptom Inventory (NPSI)
This questionnaire is used to capture the severity of neuropathic pain symptoms.
Time frame: This will be measured at baseline, week 13 and at 6-month follow-up.
Electroencephelography (EEG)
Resting EEG signals (3 minutes eyes open, 3 minutes eyes closed) for alpha, beta and theta band powers will be assessed using the NeuroCONCISE 8.
Time frame: This will be measured at baseline, week 13 and at 6-month follow-up.
Plan to share: Yes — 1 year after the end of the project the master data sheet will be destroyed and anonymised files will be deposited in a secure data repository (Zenodo) with a permanent identifier (DOI) and available to the wider research community under a CC0 license. Participants will have an opportunity to consent or not to anonymised data archiving. In line with HRB Open Research Policy, repositories hosting the data will be cited in research papers.
Supporting information: Study protocol, Icf, Csr
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University College Dublin