Trial Review

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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
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
Secondary ID [1] 310076 0
Nil known
Universal Trial Number (UTN)
Trial acronym
tRESTORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 330617 0
loss of sensation 330618 0
Condition category
Condition code
Neurological 327453 327453 0 0
Other neurological disorders
Injuries and Accidents 327511 327511 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326479 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335316 0
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.
Timepoint [1] 335316 0
At baseline and at intervention completion (primary endpoint; between 20-28 days after baseline)
Secondary outcome [1] 423886 0
Sensorimotor function assessed using Quantitative Sensory Testing (QST)
Timepoint [1] 423886 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [2] 423887 0
The characteristics and symptoms of pain will be assessed using the DN4 (Douleur Neuropathique)
Timepoint [2] 423887 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [3] 423888 0
The intensity and specific qualities of neuropathic pain will be measured using a Numeric Rating Scale (NRS)
Timepoint [3] 423888 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [4] 423889 0
Depression will be assessed using the The Patient Health Questionnaire (PHQ)-9
Timepoint [4] 423889 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [5] 423890 0
Sleep quality will be assessed using the PROMIS - Sleep Disturbance module
Timepoint [5] 423890 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [6] 423891 0
The degree of positive affect and well-being will be assessed using the Neuro quality of life (QOL) Positive Affect & Well Being
Timepoint [6] 423891 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [7] 423892 0
The degree of satisfaction with participation in social roles and activities will be assessed using the Neuro-QOL Satisfaction with Social Roles and Activities
Timepoint [7] 423892 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [8] 423893 0
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
Timepoint [8] 423893 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [9] 423894 0
Participant's sexual concerns will be assessed using the International spinal cord injury sexual function basic data sets—version 2.0
Timepoint [9] 423894 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [10] 423895 0
Female sexual function will be assessed using the International SCI Female Sexual and Reproductive Function Basic Data Set – Version 2
Timepoint [10] 423895 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [11] 423896 0
Male sexual function will be assessed using the International SCI Male Sexual Function Basic Data Set – Version 2
Timepoint [11] 423896 0
At baseline and at intervention completion (between 20-28 days after baseline)
Secondary outcome [12] 423897 0
The efficacy of the intervention (the VR HapticWalk game) will be assessed using the Treatment Evaluation Inventory (TEI)
Timepoint [12] 423897 0
Administered at intervention completion (between 20-28 days after baseline)
Secondary outcome [13] 423898 0
Participants’ perceived change in sensation intensity following the intervention will be assessed using the Patient Global Impression of Change (PGIC) Scale
Timepoint [13] 423898 0
Administered at intervention completion (between 20-28 days after baseline)
Secondary outcome [14] 423899 0
The degree to which the participants experience embodiment will be assessed using the Avatar Embodiment Questionnaire
Timepoint [14] 423899 0
Administered at intervention completion (between 20-28 days after baseline) only
Secondary outcome [15] 423900 0
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
Timepoint [15] 423900 0
Administered at intervention completion (between 20-28 days after baseline) only
Secondary outcome [16] 423901 0
Discomfort during the VR gaming sessions will be assessed using the Simulator Sickness Questionnaire (SSQ)
Timepoint [16] 423901 0
Administered at intervention completion (between 20-28 days after baseline) only

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
19/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314242 0
Charities/Societies/Foundations
Name [1] 314242 0
Wings for Life
Country [1] 314242 0
United Kingdom
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney, High Street, Gate 2, Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 316174 0
None
Name [1] 316174 0
Address [1] 316174 0
Country [1] 316174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313360 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 313360 0
Ethics committee country [1] 313360 0
Australia
Date submitted for ethics approval [1] 313360 0
01/08/2023
Approval date [1] 313360 0
18/09/2023
Ethics approval number [1] 313360 0
HC230497

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127878 0
Prof Sylvia Gustin
Address 127878 0
NeuroRecovery Research Hub
School of Psychology
Biomedical Sciences Building, Level 1
Library Walk 1
UNSW Sydney
Kensington NSW 2052
Country 127878 0
Australia
Phone 127878 0
+61 2 9065 1881
Fax 127878 0
Email 127878 0
s.gustin@unsw.edu.au
Contact person for public queries
Name 127879 0
Sylvia Gustin
Address 127879 0
NeuroRecovery Research Hub
School of Psychology
Biomedical Sciences Building, Level 1
Library Walk 1
UNSW Sydney
Kensington NSW 2052
Country 127879 0
Australia
Phone 127879 0
+61 2 9065 1881
Fax 127879 0
Email 127879 0
s.gustin@unsw.edu.au
Contact person for scientific queries
Name 127880 0
Sylvia Gustin
Address 127880 0
NeuroRecovery Research Hub
School of Psychology
Biomedical Sciences Building, Level 1
Library Walk 1
UNSW Sydney
Kensington NSW 2052
Country 127880 0
Australia
Phone 127880 0
+61 2 9065 1881
Fax 127880 0
Email 127880 0
s.gustin@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data of published results will be made available upon reasonable request
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.
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.
Available for what types of analyses?
Data will be available for secondary analyses, including meta-analyses
How or where can data be obtained?
Request to the data custodian, the Principal Investigator (s.gustin@unsw.edu.au). Data transfer to other researchers will be organised by sharing a link to a secure UNSW OneDrive folder.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19634Study protocol  s.gustin@unsw.edu.au
19635Informed consent form  s.gustin@unsw.edu.au
19636Ethical approval  s.gustin@unsw.edu.au



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.