Efficacy of transcutaneous spinal cord stimulation combined with locomotor training to improve walking ability in people with chronic spinal cord injury: a multi-centre double-blinded randomised sham-controlled trial (eWALK2.0)
- Conditions
- spinal cord injuryparalysisNeurological - Other neurological disordersPhysical Medicine / Rehabilitation - Other physical medicine / rehabilitation
- Registration Number
- ACTRN12624000380594
- Lead Sponsor
- euroscience Research Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 88
A person will be eligible to participate if they:
•have a SCI sustained a minimum of 12 months prior to consent
•have a motor level between C2-T11 on one or both sides
•have a spinally evoked muscle reflex in at least one quadriceps muscle in response to transcutaneous spinal stimulation
•have a total lower limb International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor score of at least 4/50
•are willing and able to participate in the training program 3 times a week for 12 weeks, including a follow-up telephone call at 6 months after randomisation
•are able to take at least two steps with no harnessed body weight support. The steps may be completed with assistance (physically swinging the leg through by the therapist is not allowed), braces, gait aids or within parallel bars.
•are able to give informed consent and aged 16 years or over at the time of consent
•are considered by their spinal specialist to be medically stable to undertake the program (including clearance for standing/locomotor training)
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 50% of the intensity required to evoke a reflex in the quadricep muscle
•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 multiple long-bone fractures, family history of fragility fracture or any disorders of the bone, such as Paget’s disease
•have a progressive syringomyelia (syrinx) on serial MRI. Radiological findings that have been evaluated by a neurosurgeon as non-progressive may still be eligible
•have had open surgery within the last 3 months
•have severe lower limb spasticity or contracture that will interfere with the training program
•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 (for experimental group) or sham (for control group)[Walking ability will be measured using the Two Minute Walk Test (2MWT) in metres. The primary timepoint is 13 weeks after randomisation. The primary outcome will also be measured at Day 0 (one day after randomisation).]
- Secondary Outcome Measures
Name Time Method