None listed
Conditions
Brief summary
Spinal cord injury involves damage to spinal cord that causes loss of movement, sensation and physical function. Spinal cord injury is common in Australia. People with spinal cord injury live with weakness, loss of dexterity, spasticity and contracture (loss of joint range of motion). The use of electrical stimulation as a treatment modality may improve function in people with a spinal cord injury by decreasing problematic spasticity. The Mollii electrodress suit was developed to improve function in people with neurological conditions. The Mollii suit consists of long-sleeved upper and lower body garments with implanted electrodes that deliver customised low-level electrical stimulation. At present, small studies suggest that wearing the Mollii suit improves function in some neurological conditions but not others. Receiving stimulation through wearing the suit for 60 minutes may improve function and spasticity temporarily for people with a spinal cord injury, but no studies have formally investigated this. This study aims to determine if receiving stimulation through wearing the Mollii suit for a single 60-minute session produces short-term improvements in function and spasticity in people with chronic spinal cord injury.
Interventions
The Mollii Electrodress (TGA approved) suit consists of separate, long-sleeved upper and lower body garments with implanted electrodes that deliver customised low-level electrical stimulation. People wear both garments of the suit for one hour at a time while performing activities of daily living on two separate occasions, one week apart. The electrodes of the suit are set by a trained Mollii Suit Therapist at 20volts, with a pulse width between 25-175us, at 20Hz. On the one occasion (randomised
The Mollii Electrodress (TGA approved) suit consists of separate, long-sleeved upper and lower body garments with implanted electrodes that deliver customised low-level electrical stimulation. People wear both garments of the suit for one hour at a time while performing activities of daily living on two separate occasions, one week apart. The electrodes of the suit are set by a trained Mollii Suit Therapist at 20volts, with a pulse width between 25-175us, at 20Hz. On the one occasion (randomised) the participant will wear the suit for one hour, but the customised configuration will not deliver the electrical stimulation. The parameters are designed so that regardless of if the stimulation Mollii suit is turn on or not, there is not visible muscle contraction nor is there noticeable sensation of electrical stimulation. The effectiveness of the intervention will be assessed before and after wearing the suit for one hour, and 2 days after removal. The duration of suit application, activities performed and electrical stimulation parameters of the suit for each person will be recorded for the two occasions it is worn.
Sponsors
Neuroscience Research Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be included if they: • have spinal cord injury • have spasticity, defined as scoring at least 1 on the Modified Tardieu Scale • are able to perform the Timed Up and Go test • do not have implanted devices (e.g. pacemaker, Baclofen pump)
Exclusion criteria
Participants will not be included if they: • have a history of clinically significant autonomic dysreflexia in response to electrical stimulation • have a history of hypotension in response to prolonged standing • have a history of long-bone fracture, family history of fragility fracture or any disorders of the bone, such as Paget’s disease that prevents standing for up to 60 minutes • have extensive lower limb contractures (limiting ROM by at least 30% within normal ranges required for ambulation) • have any contraindications to electrical stimulation such as cardiac pacemaker, baclofen pump, pregnancy, or hardware near the stimulation site • are actively participating in any other clinical trials or are still in the follow-up period of a clinical trial
Outcome results
None listed