None listed
Conditions
Brief summary
We will conduct a multi-centred, double-blind randomised sham-controlled trial on 88 people with chronic SCI. The primary outcome will be walking ability measured using the Two Minute Walk Test (2MWT) with stimulation. Participants will be randomised to either the Stimulation group or the Sham group. All participants will receive the same intensive locomotor training consisting of three thirty minute sessions per week, over 12 weeks, in combination with either stimulation or sham stimulation. The secondary outcomes will capture different aspects of recovery, strength, spasticity, and quality of life. Outcome measures will be taken at baseline, Day 0, 13-weeks and 6-months after randomisation. Our hypothesis is that spinal stimulation plus locomotor training in chronic SCI will improve walking ability, demonstrated by a clinically important change on the 2 Minute Walk test and that spinal stimulation will be a feasible and safe treatment that can be provided in a community setting.
Interventions
All participants will receive three 30 minute locomotor training sessions combined with either spinal stimulation or sham each week over 12 weeks. The locomotor training will consist of walking on a treadmill and overground for 30 minutes. Each week the participant will attend one session dedicated to overground walking while the other two sessions will be spent walking on the treadmill. Training will be delivered by one experienced spinal physiotherapist or exercise physiologist and up to two a
All participants will receive three 30 minute locomotor training sessions combined with either spinal stimulation or sham each week over 12 weeks. The locomotor training will consist of walking on a treadmill and overground for 30 minutes. Each week the participant will attend one session dedicated to overground walking while the other two sessions will be spent walking on the treadmill. Training will be delivered by one experienced spinal physiotherapist or exercise physiologist and up to two assistants as required. Participants will be allowed seated or standing rests as needed throughout the training session. The rest periods will not contribute to the overall 30 minutes of training. The stimulation/sham will be turned off immediately if participants indicate they need to sit down to rest. The stimulation will be turned back on once the participant is back standing or resumes walking. If participants require a rest but can stay standing, the stimulation/sham will stay on and a timer will be started by one of the therapists. If the participant does not resume locomotor training within 1 minute, the stimulation or sham will be turned off. A maximum of 60 minutes will be allotted to complete the 30 minutes of locomotor training regardless of whether 30 minutes of locomotor training with stimulation/sham has been completed.. Speed and body-weight support (BWS) will be adjusted throughout the training program to adapt training intensity. On the first training day, the amount of BWS will be assessed. Excessive knee flexion during stance phase (i.e., > 40°) or toe dragging during swing phase will be indicators of insufficient BWS. The amount of BWS required for overground versus treadmill walking may differ. Body-weight support will be reviewed at the end of each week with the goal of imposing maximum lower extremity weight bearing while maintaining proper locomotor biomechanics. No orthoses or gait aids will be worn while walking on the treadmill.. For overground training sessions, participants will be encouraged to walk at a comfortable pace throughout. Orthoses, gait aides, parallel bars or safety harnesses will be used on a case-by-case basis for optimising safety and will be documented in the participants training diaries along with any changes. The details of each training session provided to participants will be recorded by the therapist in a training diary. If a participant is unable to attend one of the weekly training sessions, a makeup session will be attempted to ensure they attend three sessions a week. Reasons if unable to attend will be documented in the training diary. Transcutaneous spinal stimulation will be applied with the anode (5 x 10 cm) placed horizontally over the lower abdomen and the cathode (5x10 cm) placed vertically over the lower thoracic/upper lumbar region (T10-L2). Stimulation will consist of an 800 – 1000 microseconds duration biphasic rectangular-wave pulse delivered at 20 Hz. The stimulus intensity will be set to the intensity found to evoke posterior-root muscle (PRM) reflexes in the quadriceps muscles (highest intensity between left and right sides) with a single pulse (i.e. threshold intensity) or to participants’ maximum tolerance, whichever is lowest. The PRM intensity will be re-assessed every four weeks as it can change across sessions. All stimuli will be delivered via a Digitimer Biphasic Constant Current multi-modal stimulator (DS8R) controlled by a custom-made control box designed by NeuRA.
Sponsors
Neuroscience Research Australia
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Outcome results
None listed