To investigate transcutaneous spinal cord stimulation combined with locomotor training on walking ability in people with chronic spinal cord injury: a multi-centre double-blinded randomised sham-controlled trial (eWALK)
- Conditions
- spinal cord injuryNeurological - Other neurological disordersInjuries and Accidents - Other injuries and accidents
- Registration Number
- ACTRN12620001241921
- Lead Sponsor
- euroscience Research Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
A person will be eligible to participate if they:
• have a SCI sustained a minimum of 12 months prior to consent
• have bilateral motor levels between T1 and T11
• have a Walking Index for Spinal Cord Injury II (WISCI II) between Level 1 and 6*
• have a reproducible, voluntary muscle flicker/contraction in at least one muscle that flexes or extends the hip, knee, ankle or big toe, on either side of the body
• are willing and able to participate in the stimulation/locomotor training program 3 times a week for 12 weeks, including one follow-up visit at 16 weeks
• are aged 16 years or over at the time of consent and able to give informed consent
• are considered by their spinal specialist to be medically stable to undertake the program (including clearance for standing/locomotor training)
*1 = Ambulates in parallel bars, with braces and physical assistance of two persons, but less than 10 metres
6 = Ambulates with walker, with braces and physical assistance of one person, 10 metres
A person will be ineligible to participate if they:
•have a history of clinically significant autonomic dysreflexia in response to electrical stimulation
•cannot tolerate transcutaneous spinal stimulation at a therapeutic intensity
•have a history of hypotension in response to prolonged standing
•have a progressive neurological disease and any other major neurological lesion additional to the spinal cord injury, e.g., a severe traumatic brain injury or stroke
•have a history of long-bone fracture, family history of fragility fracture or any disorders of the bone, such as Paget’s disease
•have a syringomyelia (syrinx) on recent MRI. Radiological findings such as myelomalacia which have been evaluated by a neurosurgeon as non-progressive may still be eligible
•have had open surgery within the last 3 months
•unable to elicit reflexes whilst experiencing the stimulation suggesting a lower motor neurone lesion
•have severe lower limb spasticity (MAS = 4 in any lower limb muscle)
•have extensive lower limb contractures preventing ambulation
•have any serious medical condition, cognitive impairment, drug dependency, psychiatric illness or behavioural problem preventing them from adhering to the protocol
•have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification
•have a previous pressure ulcer treated with a myocutaneous flap using a graft from a locomotor muscle such as the gluteal or hamstring
•have any contraindications to electrical spine stimulation such as cardiac pacemaker, lower limb fracture, baclofen pump, pregnancy, or implanted electronic devices
•have an upper limb injury preventing prolonged weight bearing through their arms
•have had stem cell or olfactory ensheathing cell therapy within the last 5 years
•are actively participating, or are in the follow-up period, of any other clinical trials
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Walking ability with stimulation: Walking ability will be measured using the Walking Index for Spinal Cord Injury II (WISCI II). It considers the amount of physical assistance, braces or devices (parallel bars, walker or cane) required to walk 10 metres. An experienced therapist will rate the participants. [Day 1 post-randomisation, 12 weeks (primary timepoint), and 16 weeks post-randomisation]
- Secondary Outcome Measures
Name Time Method