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Trial registered on ANZCTR
Registration number
ACTRN12623000808640
Ethics application status
Approved
Date submitted
7/07/2023
Date registered
27/07/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
27/07/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of Immersive Virtual Reality and Spinal Transcutaneous Electrical Stimulation on Touch Perception in People with Discomplete Paraplegia
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Scientific title
tRESTORE: A Pilot Single-arm Study of the effect of Haptic Virtual Reality and Spinal Transcutaneous Electrical Stimulation on Somatosensory Perception in Discomplete Spinal Cord Injury
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Secondary ID [1]
310076
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
tRESTORE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
spinal cord injury
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loss of sensation
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Condition category
Condition code
Neurological
327453
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0
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Other neurological disorders
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Injuries and Accidents
327511
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
326479
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary outcome is, on physical examination according to the International Standards for Neurological Classification of Spinal Cord Injury, a change in sensory perception for touch sensation within at least one dermatome on either side of the body at or below the level of injury. A cotton swab will be used to generate the touch sensation.
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Assessment method [1]
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Timepoint [1]
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At baseline and at intervention completion (primary endpoint; between 20-28 days after baseline)
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Secondary outcome [1]
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Sensorimotor function assessed using Quantitative Sensory Testing (QST)
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Assessment method [1]
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Timepoint [1]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [2]
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The characteristics and symptoms of pain will be assessed using the DN4 (Douleur Neuropathique)
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Assessment method [2]
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Timepoint [2]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [3]
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The intensity and specific qualities of neuropathic pain will be measured using a Numeric Rating Scale (NRS)
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Assessment method [3]
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Timepoint [3]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [4]
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Depression will be assessed using the The Patient Health Questionnaire (PHQ)-9
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Assessment method [4]
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Timepoint [4]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [5]
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Sleep quality will be assessed using the PROMIS - Sleep Disturbance module
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Assessment method [5]
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Timepoint [5]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [6]
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The degree of positive affect and well-being will be assessed using the Neuro quality of life (QOL) Positive Affect & Well Being
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Assessment method [6]
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Timepoint [6]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [7]
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The degree of satisfaction with participation in social roles and activities will be assessed using the Neuro-QOL Satisfaction with Social Roles and Activities
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Assessment method [7]
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Timepoint [7]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [8]
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Self-rated level of health in multiple domains and then generates a single score that integrates all domains will be measured using the PROMIS Global Health
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Assessment method [8]
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Timepoint [8]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [9]
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Participant's sexual concerns will be assessed using the International spinal cord injury sexual function basic data sets—version 2.0
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Assessment method [9]
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Timepoint [9]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [10]
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Female sexual function will be assessed using the International SCI Female Sexual and Reproductive Function Basic Data Set – Version 2
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Assessment method [10]
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Timepoint [10]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [11]
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Male sexual function will be assessed using the International SCI Male Sexual Function Basic Data Set – Version 2
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Assessment method [11]
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Timepoint [11]
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At baseline and at intervention completion (between 20-28 days after baseline)
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Secondary outcome [12]
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The efficacy of the intervention (the VR HapticWalk game) will be assessed using the Treatment Evaluation Inventory (TEI)
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Assessment method [12]
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Timepoint [12]
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Administered at intervention completion (between 20-28 days after baseline)
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Secondary outcome [13]
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Participants’ perceived change in sensation intensity following the intervention will be assessed using the Patient Global Impression of Change (PGIC) Scale
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Assessment method [13]
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Timepoint [13]
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Administered at intervention completion (between 20-28 days after baseline)
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Secondary outcome [14]
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The degree to which the participants experience embodiment will be assessed using the Avatar Embodiment Questionnaire
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Assessment method [14]
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Timepoint [14]
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Administered at intervention completion (between 20-28 days after baseline) only
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Secondary outcome [15]
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Participant agreement/disagreement with a series of statements about their experience during and after the intervention (VRHapticWalk) will be assessed using the VR Experience (VRE) questionnaire
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Assessment method [15]
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Timepoint [15]
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Administered at intervention completion (between 20-28 days after baseline) only
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Secondary outcome [16]
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Discomfort during the VR gaming sessions will be assessed using the Simulator Sickness Questionnaire (SSQ)
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Assessment method [16]
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Timepoint [16]
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Administered at intervention completion (between 20-28 days after baseline) only
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/12/2023
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Actual
19/02/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
12
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
314242
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Charities/Societies/Foundations
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Name [1]
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Wings for Life
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Address [1]
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42-56 Earlham Street
London WC2H 9LA
Great Britain
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Country [1]
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United Kingdom
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Primary sponsor type
University
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Name
University of New South Wales
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Address
UNSW Sydney, High Street, Gate 2, Kensington NSW 2052
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
316174
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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UNSW Human Research Ethics Committee
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Ethics committee address [1]
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UNSW Sydney, High Street, Gate 2, Kensington NSW 2052
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/08/2023
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Approval date [1]
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18/09/2023
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Ethics approval number [1]
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HC230497
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sylvia Gustin
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Address
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NeuroRecovery Research Hub
School of Psychology
Biomedical Sciences Building, Level 1
Library Walk 1
UNSW Sydney
Kensington NSW 2052
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Country
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Australia
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Phone
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+61 2 9065 1881
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Fax
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Email
127878
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[email protected]
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Contact person for public queries
Name
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Prof Sylvia Gustin
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Address
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NeuroRecovery Research Hub
School of Psychology
Biomedical Sciences Building, Level 1
Library Walk 1
UNSW Sydney
Kensington NSW 2052
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Country
127879
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Australia
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Phone
127879
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+61 2 9065 1881
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Fax
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Email
127879
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[email protected]
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Contact person for scientific queries
Name
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Prof Sylvia Gustin
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Address
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NeuroRecovery Research Hub
School of Psychology
Biomedical Sciences Building, Level 1
Library Walk 1
UNSW Sydney
Kensington NSW 2052
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Country
127880
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Australia
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Phone
127880
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+61 2 9065 1881
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Fax
127880
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual participant data of published results will be made available upon reasonable request
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When will data be available (start and end dates)?
Data will be made available after the publication of study reports. There is no end date for the availability of study data.
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Available to whom?
Only upon reasonable request, researchers who wish to access the data will need to provide a copy of their ethics approval to do so before the data is shared for secondary research purposes. A copy of the researchers’ ethics approval will be kept for records, and for monitoring with UNSW Sydney HREC.
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Available for what types of analyses?
Data will be available for secondary analyses, including meta-analyses
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How or where can data be obtained?
Request to the data custodian, the Principal Investigator (
[email protected]
). Data transfer to other researchers will be organised by sharing a link to a secure UNSW OneDrive folder.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19634
Study protocol
[email protected]
19635
Informed consent form
[email protected]
19636
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF