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Effect of Immersive Virtual Reality on Touch Perception in People with Discomplete Paraplegia

RESTORE: A Pilot Single-arm Study of the Effect of Immersive Virtual Reality Treatment on Touch Perception in People with Discomplete Paraplegia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000561785
Acronym
RESTORE
Enrollment
4
Registered
2022-04-12
Start date
2026-01-28
Completion date
2029-08-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Complete spinal cord injury (SCI) is associated with total loss of sensorimotor function below the level of injury. However, in a recent breakthrough finding we revealed that 50% of individuals with a complete SCI still have preserved spinal somatosensory nerve fibres. In our study, we stimulated the big toe of individuals with complete paraplegia while they were undergoing functional neuroimaging. Although our participants did not feel the touch, a significant signal was mediated within brain areas associated with perception of touch, including the somatosensory cortices. This became the first objective evidence of discomplete SCI – the idea that many spinal cord injured people who cannot feel still have touch information forwarded from the periphery (parts of their body, e.g. big toe) to the brain. The recognition of surviving nerve fibres in complete injuries has tremendous implications for physical and psychological adjustment. However, currently there are no effective interventions to promote or restore touch perception following SCI. We propose to draw on our recent discovery and on biological and technological innovations in SCI to develop and test a novel intervention to restore touch perception among individuals previously classified as having complete perceptual loss. The proposed intervention (Virtual Reality Haptic Walking/VRHapticWalk) will capitalize on the haptic, volitional, and embodiment capabilities of the existing technological interface to simultaneously enhance surviving somatosensory spinal nerve fibres and somatosensory (touch) signals in the brain in an effort to restore touch perception among individuals with discomplete SCI. In other words, subjects will receive touch simulation in the real world (e.g., the sole of their foot) while at the same time receiving corresponding multisensory touch stimuli in the virtual world. In people with discomplete SCI, the resultant superadditive effects of simultaneously enhanced peripheral/spinal and cortical somatosensory system activity is expected to lead to recovery of the disrupted sensorimotor system and further promote touch restoration. A growing body of evidence supports the role of superadditive effects in sensorimotor restoration in SCI. This project brings together front-line innovation in basic scientific understanding of neurological changes in SCI and cutting-edge clinical applications of virtual reality to provide a tangible outcome for SCI people in Australia. The outcomes to be achieved from this project were not deemed possible a year ago and will represent a cultural and scientific paradigmatic shift in terms of what can be expected from life with a spinal cord injury.

Interventions

This is a single-arm pilot treatment trial. Participants will not be supervised, but the research team will have access to the virtual reality (VR) software (VRHapticWalk) logs to monitor adherence to the intervention. Participants will be able to utilize volitional walking elements; specifically, participants will use gait-associated arm motions with hand controllers which are attached to their wrists, to control their virtual legs and walking activity in the virtual environment. Simultaneously

This is a single-arm pilot treatment trial. Participants will not be supervised, but the research team will have access to the virtual reality (VR) software (VRHapticWalk) logs to monitor adherence to the intervention. Participants will be able to utilize volitional walking elements; specifically, participants will use gait-associated arm motions with hand controllers which are attached to their wrists, to control their virtual legs and walking activity in the virtual environment. Simultaneously they will receive haptic feedback associated with the virtual walking environment via the foot device. An initial 1 min “Orientation” environment will serve to familiarize participants with virtual ambulation and interaction with the virtual environment. Then the subjects will participate in 21 min daily sessions for 20 days at either UNSW or home. Each treatment session will be divided into three 7 minute sections with 3 minutes break in between [(7 min treatment + 3 min break) x 3 repeats]. The interactive virtual walking experience is facilitated by a commercially available head-mounted display (HMD), wearable hand controllers and a foot device with haptic feedback. Participants’ arms and legs are represented from a first-person perspective within a fully immersive 360-degree 3D virtual scene. The individual participant's avatar legs will be the primary modality of interaction with the virtual world. Simple obstacles will call for subject interaction with the VR world, e.g., walking on/touching sand/snow/gravel. Analogous biological body areas will be concurrently stimulated. Haptic stimulation via soft tactile actuators will be applied using a foot device on participants’ actual feet (soles of feet bilaterally) and corresponding visual input provided in the virtual environment. Participation does not require transfer from personal chair equipment and is compatible with various chair types.

Sponsors

UNSW Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The study will recruit individuals with complete (according to the American Spinal Injury Association [ASIA] classification A) thoracic injury. Additional criteria will include: a) age of 18 or more b) more than 3 months post-injury c) on MRI scanning evidence of signal in brain areas in response to touch below the injury level d) ability to fully participate in the VRHapticWalk intervention (must be able to move both arms at least a little)

Exclusion criteria

a) incompatible for MRI b) on MRI scanning, no evidence of signal in brain areas in response to touch below the injury level c) have been diagnosed with an inner ear/balance disorder and commonly suffer motion sickness or vertigo d) have vascular or other major disease e) have a significant visual impairment f) have an active pressure injury g) have an unhealed foot fracture h) inability to comprehend spoken English

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 25, 2026