Virtual Walking to Reduce Chronic Neuropathic Pain in Subjects With SCI
NCT ID: NCT07165353
Last Updated: 2026-01-21
Study Results
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Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2026-01-20
2027-11-30
Brief Summary
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This study will test whether virtual walking from different visual perspectives can reduce chronic neuropathic pain and improve quality of life after spinal cord injury. We will also compare which perspective works best.
To better understand how the training works, we will use two tests-quantitative sensory testing (QST) and contact heat-evoked potentials (CHEPs)-to measure changes in the pain and nerve systems.
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Detailed Description
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MRI data show, that there is a correlation between the grade of cortical reorganisation and pain intensity in people with complete SCI (Gustin et al., 2023). However, it is unclear whether there is a systematic influence of the severity of the SCI lesion, graded by the American Spinal Injury Association (ASIA) Impairment Scale (complete or incomplete SCI), on pain intensity.
Alongside with studies about pain mechanisms and improved pharmaceutical treatment, non-invasive and non-pharmacological alternative treatments with minimal side effects have been investigated, such as, for example virtual reality (VR). Changes of pain perception due to VR interventions in individuals with neuropathic spinal cord injury pain (SCIP) are described in the literature (Eick \& Richardson, 2015; Kumru et al., 2013; Moseley, 2007; Özkul et al., 2015; Soler et al., 2010; Trost et al., 2022). Recent reviews have shown good short-term effects of VR in the treatment of SCIP (Chi et al., 2019; de Araújo et al., 2019). However, there is lack of evidence from randomized controlled trials.
Chronic pain in SCI is often modulated by psycho-social factors such as depression, anxiety, extent of social support and pain catastrophising (Braunwalder et al., 2022; Braunwalder et al., 2021; Müller et al., 2017; Wollaars et al., 2007). Data about the influence of psycho-social factors on VR therapy are only reported for VR therapy in first person perspective (Trost et al., 2022). Data about the influence of psycho-social factors third person perspective are not available.
Recently, a virtual walking (VW) treatment protocol in third person perspective inclusive an additional haptic feedback modality (controlled movement of the wheelchair seat to improve the walking immersion) has been set up and evaluated within a feasibility study with individuals with SCIP, reporting a high level of satisfaction and acceptance of the VW procedure at the Centre for Pain Medicine, Swiss Paraplegic Centre (SPC), Nottwil. In this uncontrolled explorative trial, there was a tendency towards reduced pain intensity and spread of reported pain after VW (Aerni, 2020).
To better understand individual responses to VR and explore underlying pain mechanisms, neurophysiological assessments such as quantitative sensory testing (QST) and contact heat-evoked potentials (CHEPs) are used as biomarkers to identify sensory phenotypes.
To address the challenges of assessing and treating pain following SCI, the systematic evaluation of all somatosensory submodalities is strongly recommended for both pathophysiological research and treatment trials in individuals with SCI-related pain (Finnerup, 2013).
Landmann et al. (2024) demonstrated that QST can identify distinct sensory phenotypes in individuals with neuropathic spinal cord injury pain (SCIP). Furthermore, the combination of QST and CHEPs enables objective and standardized measurement of sensory system alterations, thereby contributing to a better understanding of underlying mechanisms (Opsommer et al., 2021).
The aim of the present study is to evaluate (1) the efficiency of the standardised VW-setting with regard to pain reduction in subjects with complete and incomplete SCI, (2) bio-psycho-social prognostic factors which may influence the efficacy of VR, and (3) the influence of VR on psycho-social characteristics of subjects with SCI and (4) to identify pain and sensory phenotypes in individuals with SCIP and examine whether these phenotypes are associated with differential effects of VR on pain reduction..
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1
Participants will receive virtual walking (VW) therapy with a personalized avatar. Using a green screen setup, a live video of the participant's upper body is combined with pre-recorded walking legs to create a full-body walking illusion, displayed on a large projection screen in a forest environment. The participant will be seated in a modified wheelchair that tilts 2° to each side to simulate pelvic movement during walking.
Virtual Walking
This virtual walking therapy uses a life-sized video avatar of the participant walking through a forest environment. A green screen setup combines a live video of the participant's upper body with pre-recorded walking legs, creating a full-body walking illusion. The participant is seated in a modified wheelchair that tilts 2° to each side to mimic pelvic movement during walking. This approach differs from the sham condition (Group 2), which displays only the moving forest without an avatar or wheelchair tilt, and from the standard care group (Group 3), which receives no virtual walking therapy.
Group 2
Participants will receive virtual walking (VW) therapy without an avatar. The screen will display only a moving forest environment, and the wheelchair tilt will be omitted. This condition serves as a sham intervention, matching Group 1 in session number, duration, and procedure, but without the visual and vestibular walking components.
Sham Virtual Walking
Participants view a moving forest environment on a large projection screen for 10 sessions over 2 weeks (each up to 20 minutes). No avatar of the participant is displayed, and the wheelchair tilt function is disabled. This differs from the experimental intervention (Group 1), which includes a life-sized walking avatar and wheelchair tilt to mimic pelvic movement, and from the standard care group (Group 3), which receives no virtual walking therapy.
Control Group
Participants will receive standard medical pain management only. They will not take part in virtual walking therapy but will complete the pain diary and questionnaires at the scheduled assessment time points.
No interventions assigned to this group
Interventions
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Virtual Walking
This virtual walking therapy uses a life-sized video avatar of the participant walking through a forest environment. A green screen setup combines a live video of the participant's upper body with pre-recorded walking legs, creating a full-body walking illusion. The participant is seated in a modified wheelchair that tilts 2° to each side to mimic pelvic movement during walking. This approach differs from the sham condition (Group 2), which displays only the moving forest without an avatar or wheelchair tilt, and from the standard care group (Group 3), which receives no virtual walking therapy.
Sham Virtual Walking
Participants view a moving forest environment on a large projection screen for 10 sessions over 2 weeks (each up to 20 minutes). No avatar of the participant is displayed, and the wheelchair tilt function is disabled. This differs from the experimental intervention (Group 1), which includes a life-sized walking avatar and wheelchair tilt to mimic pelvic movement, and from the standard care group (Group 3), which receives no virtual walking therapy.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18y, ≤ 75y
* Chronic traumatic or non-traumatic SCI (\>6 month after SCI) with an SCI severity grade AIS A, B, C or D
* At or below level spinal cord injury neuropathic pain on trunk or lower extremities diagnosed by a neurologist following the ISCIP classification (Bryce et al., 2012) of at least 4/10 intensity on a NRS (Langford et al., 2023)
* Ability to draw with a pen
Exclusion Criteria
* Participants with a walking ability more than 5 minutes without walking aids
* Pregnancy (anamnestic) in women of child-bearing age (18-49 years)
* Known epilepsy
* neurological disorders (multiple sclerosis, ALS, Guillan-Barré Syndrome, congenital disorders, polyneuropathy)
18 Years
75 Years
ALL
No
Sponsors
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Swiss Paraplegic Research, Nottwil
NETWORK
Responsible Party
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Principal Investigators
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Gunther Landmann, KD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Schweizer Paraplegiker Zentrum Nottwil
Locations
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Schweizer Paraplegiker Zentrum Nottwil
Nottwil, Canton of Lucerne, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2023-17
Identifier Type: -
Identifier Source: org_study_id
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