None listed
Conditions
Brief summary
We will conduct a multi-centred, double-blind randomised sham-controlled trial on 50 people with chronic SCI. The primary outcome will be walking ability measured using the Walking Index for SCI II (WISCI II). 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 one hour 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 bowel function. Outcome measures will be taken at baseline, 12 weeks and 16 weeks after randomisation.
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 participant will attend one session dedicated to overground walking only while the other two sessions will be spent walking on the treadmill. Training will be delivered by one experienced spinal physiotherapist and up to two assistants as required.
Part
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 participant will attend one session dedicated to overground walking only while the other two sessions will be spent walking on the treadmill. Training will be delivered by one experienced spinal physiotherapist and up to two assistants as required. Participants will be allowed either 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 a participant indicates they need to sit down to rest. If a participant requires 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 stimulator will be turned off. A maximum of 60 minutes will be allotted to complete the 30 minutes of locomotor training. Speed and body-weight support (BWS) are the two parameters that will be adjusted throughout the training program to change training intensity. Body-weight support will be reviewed at the end of each week with the goal of imposing maximum lower extremity weight bearing. The speed for all participants will start at 0.2m/s on the first training day and will be slowly increased throughout the training session as tolerated. Speed will be decreased if the stepping quality begins to degrade (e.g., excessive knee flexion during stance phase or toe dragging during swing phase). 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. However, knee-ankle-foot orthoses will not be used during locomotor training. Manual assistance to the lower limbs will be provided as required to enhance motor learning and improve walking patterns based on established locomotor protocols. When walking on the treadmill, participants will be permitted to hold the side rails for stability while walking. The rails will be positioned at about chest height to prevent weight bearing through the arms. As participants progress, they will be encouraged to add arm swinging if safe to do so. The details of each training session provided to participants will be recorded by the therapist in a training diary. The training diary will be used to document; whole session time, perceived exertion, braces/gait aids used, amount of body weight support and all other parameters of each training session. 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 over the lower abdomen and the cathode (3 cm diameter) over the T11-L1 level. The stimulus will be 1ms of a 10kHz biphasic square-wave, pulsed at 15-30 Hz. The stimulus intensity during the intervention will be approximately 5% above the minimal stimulus intensity that induces bilateral posterior root-muscle reflex responses. The intensity will be re-assessed fortnightly as it can decline across sessions. All stimuli will be delivered via a Digitimer Biphasic Constant Current multi-modal stimulator (DS8R).
Sponsors
Neuroscience Research Australia
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 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
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 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
Outcome results
None listed