Effect of Immersive Virtual Reality and Spinal Transcutaneous Electrical Stimulation on Touch Perception in People with Discomplete Paraplegia

Not Applicable

Recruiting

• Conditions: spinal cord injury; loss of sensation; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12623000808640
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-27
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[ At baseline and at intervention completion (primary endpoint; between 20-28 days after baseline)]