None listed
Conditions
Brief summary
The purpose of the proposed trial is to test an immersive, virtual reality haptic walking (VRHapticWalk) in combination with spinal transcutaneous electrical stimulation (tES) intervention in an effort to restore touch perception among people with discomplete spinal cord injury (SCI). While recognition of surviving pathways in some individuals with a discomplete SCI has tremendous rehabilitative opportunities, currently no effective interventions exist to promote or restore touch perception among these discomplete SCI. The proposed study offers new, exciting diagnostic and therapeutic avenues in complete SCI practice by capitalizing on identification of cases that are discomplete SCI and initiating for the first time sensory/touch rehabilitation. We hopothesise that after 20 sessions of the VRHapticWalk + spinal transcutenous electrical stimulation touch sensation will be restored. For instance, individuals with a discomplete spinal cord injury will experience sensation when someone touches them.
Interventions
The purpose of the proposed trial is to test an immersive, virtual reality haptic walking (VRHapticWalk) in combination with spinal transcutaneous electrical stimulation (tES) intervention in an effort to restore touch perception among people with discomplete spinal cord injury (SCI).
Participants will attend our UNSW NeuroRecovery Research Hub and complete 20 sessions of the VRHapticWalk+tES intervention, delivered once daily over the course of 20-28 days by a research assistant (one-on-one fa
The purpose of the proposed trial is to test an immersive, virtual reality haptic walking (VRHapticWalk) in combination with spinal transcutaneous electrical stimulation (tES) intervention in an effort to restore touch perception among people with discomplete spinal cord injury (SCI). Participants will attend our UNSW NeuroRecovery Research Hub and complete 20 sessions of the VRHapticWalk+tES intervention, delivered once daily over the course of 20-28 days by a research assistant (one-on-one face-to-face consultation); daily sessions will include an initial period to determine each participant's optimal daily stimulation intensity, followed by 20 mins of tES to ‘prime’ the surviving somatosensory spinal nerve fibres, before completing three x 7-minute periods of VRHapticWalk+tES, with 3 minutes break in between each period. To conduct tES, one electrode will be placed on the spinous process of T11, and one on L1; and two anode electrodes will be placed on the posterior iliac crests. The approximate total duration of the intervention is 45 minutes. The VRHapticWalk intervention involves participants, using gait-associated arm motions (with hand held controllers), to control their virtual legs and walking activity in the virtual environment. Simultaneously, via a haptic foot device, they will receive haptic sensation through the soles of their feet. This haptic input is synchronised with the virtual walking.
Sponsors
University of New South Wales
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
a) The study will recruit individuals with complete (according to the American Spinal Injury Association [ASIA] classification A) thoracic injury below T6. b) Have no sensation below the waist c) age of 18 or more d) more than 6 months post-injury e) on MRI scanning evidence of signal in brain areas in response to touch below the injury level f) ability to fully participate in the VRHapticWalk+tES intervention (must be able to place the soles of each foot flat on the foot device)
Exclusion criteria
a) not meeting injury type criteria (Classification: ASIA A) b) age less than 18 c) less than or equal to 6 months post-injury d) incompatible for MRI e) on MRI scanning, no evidence of signal in brain areas in response to touch below the injury level f) inability to fully participate in the VRHapticWalk+tES intervention (unable to place the soles of each foot flat on the foot device) g) have been diagnosed with an inner ear/balance disorder and commonly suffer motion sickness or vertigo h) have vascular or other major disease i) have a significant visual impairment j) have an active pressure injury k) have an unhealed foot fracture l) have severe spasticity m) have recurrent autonomic dysreflexia n) inability to comprehend spoken English o) have an unresolved urinary tract infection p) have a recent history of deep vein thrombosis q) have a history of epilepsy and/or seizures r) have any contraindications to electrical spine stimulation such as cardiac pacemaker, lower limb fracture, baclofen pump, pregnancy, metal hardware under the stimulation electrode or implanted electronic devices s) are actively participating, or are in the follow-up period, of any other clinical trials t) have ankle plantarflexion contractures > 20 degrees
Outcome results
None listed