Transcutaneous spinal cord stimulation combined with locomotor training to improve walking ability in people with chronic spinal cord injury: study protocol for an international multi-centred double-blinded randomised sham-controlled trial (eWALK).

STUDY DESIGN: An international multi-centred, double-blinded, randomised sham-controlled trial (eWALK). OBJECTIVE: To determine the effect of 12 weeks of transcutaneous spinal stimulation (TSS) combined with locomotor training on walking ability in people with spinal cord injury (SCI). SETTING: Dedicated SCI research centres in Australia, Spain, USA and Scotland. METHODS: Fifty community-dwelling individuals with chronic SCI will be recruited. Participants will be eligible if they have bilateral motor levels between T1 and T11, a reproducible lower limb muscle contraction in at least one muscle group, and a Walking Index for SCI II (WISCI II) between 1 and 6. Eligible participants will be randomised to one of two groups, either the active stimulation group or the sham stimulation group. Participants allocated to the stimulation group will receive TSS combined with locomotor training for three 30-min sessions a week for 12 weeks. The locomotor sessions will include walking on a treadmill and overground. Participants allocated to the sham stimulation group will receive the same locomotor training combined with sham stimulation. The primary outcome will be walking ability with stimulation using the WISCI II. Secondary outcomes will record sensation, strength, spasticity, bowel function and quality of life. TRIAL REGISTRATION: ANZCTR.org.au identifier ACTRN12620001241921.

Abdominal functional electrical stimulation to assist ventilator weaning in critical illness: a double-blinded, randomised, sham-controlled pilot study.

BACKGROUND: For every day a person is dependent on mechanical ventilation, respiratory and cardiac complications increase, quality of life decreases and costs increase by > $USD 1500. Interventions that improve respiratory muscle function during mechanical ventilation can reduce ventilation duration. The aim of this pilot study was to assess the feasibility of employing an abdominal functional electrical stimulation (abdominal FES) training program with critically ill mechanically ventilated patients. We also investigated the effect of abdominal FES on respiratory muscle atrophy, mechanical ventilation duration and intensive care unit (ICU) length of stay. METHODS: Twenty critically ill mechanically ventilated participants were recruited over a 6-month period from one metropolitan teaching hospital. They were randomly assigned to receive active or sham (control) abdominal FES for 30 min, twice per day, 5 days per week, until ICU discharge. Feasibility was assessed through participant compliance to stimulation sessions. Abdominal and diaphragm muscle thickness were measured using ultrasound 3 times in the first week, and weekly thereafter by a blinded assessor. Respiratory function was recorded when the participant could first breathe independently and at ICU discharge, with ventilation duration and ICU length of stay also recorded at ICU discharge by a blinded assessor. RESULTS: Fourteen of 20 participants survived to ICU discharge (8, intervention; 6, control). One control was transferred before extubation, while one withdrew consent and one was withdrawn for staff safety after extubation. Median compliance to stimulation sessions was 92.1% (IQR 5.77%) in the intervention group, and 97.2% (IQR 7.40%) in the control group (p = 0.384). While this pilot study is not adequately powered to make an accurate statistical conclusion, there appeared to be no between-group thickness changes of the rectus abdominis (p = 0.099 at day 3), diaphragm (p = 0.652 at day 3) or combined lateral abdominal muscles (p = 0.074 at day 3). However, ICU length of stay (p = 0.011) and ventilation duration (p = 0.039) appeared to be shorter in the intervention compared to the control group. CONCLUSIONS: Our compliance rates demonstrate the feasibility of using abdominal FES with critically ill mechanically ventilated patients. While abdominal FES did not lead to differences in abdominal muscle or diaphragm thickness, it may be an effective method to reduce ventilation duration and ICU length of stay in this patient group. A fully powered study into this effect is warranted. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry, ACTRN12617001180303. Registered 9 August 2017.

A preliminary investigation of mechanisms by which short-term resistance training increases strength of partially paralysed muscles in people with spinal cord injury.

STUDY DESIGN: Pretest-posttest design. OBJECTIVES: To investigate mechanisms by which short-term resistance training (6 weeks) increases strength of partially paralysed muscles in people with spinal cord injury (SCI). SETTING: Community-based setting, Sydney, Australia. PARTICIPANTS: Ten community-dwelling people with partial paralysis of elbow flexor, elbow extensor, knee flexor or knee extensor muscles following SCI (range 5 months to 14 years since injury). METHODS: Muscle architecture and strength were assessed before and after participants underwent a six week strength-training program targeting one partially paralysed muscle group. The outcome of primary interest was physiological cross sectional area (PCSA) of the trained muscle group measured using magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI). Other outcomes were changes in mean muscle fascicle length, muscle volume, pennation angle, isometric strength and muscle strength graded on a 13-point scale. RESULTS: The mean increase in maximal isometric muscle strength was 14% (95% CI, -3 to 30%) and 1.5 points (95% CI, 0.5 to 2.5) on the 13-point manual muscle test. There was no evidence of a change in muscle architecture. CONCLUSION: This study is the first to examine the mechanisms by which voluntary strength training increases strength of partially paralysed muscles in people with SCI. The data suggest that strength gains produced by six weeks of strength training are not caused by changes in muscle architecture. This suggests short-term strength gains are due to increased neural drive or an increase in specific muscle tension.

Transcutaneous spinal stimulation in people with and without spinal cord injury: Effect of electrode placement and trains of stimulation on threshold intensity.

Transcutaneous spinal cord stimulation (TSS) is purported to improve motor function in people after spinal cord injury (SCI). However, several methodology aspects are yet to be explored. We investigated whether stimulation configuration affected the intensity needed to elicit spinally evoked motor responses (sEMR) in four lower limb muscles bilaterally. Also, since stimulation intensity for therapeutic TSS (i.e., trains of stimulation, typically delivered at 15-50 Hz) is sometimes based on the single-pulse threshold intensity, we compared these two stimulation types. In non-SCI participants (n = 9) and participants with a SCI (n = 9), three different electrode configurations (cathode-anode); L1-midline (below the umbilicus), T11-midline and L1-ASIS (anterior superior iliac spine; non-SCI only) were compared for the sEMR threshold intensity using single pulses or trains of stimulation which were recorded in the vastus medialis, medial hamstring, tibialis anterior, medial gastrocnemius muscles. In non-SCI participants, the L1-midline configuration showed lower sEMR thresholds compared to T11-midline (p = 0.002) and L1-ASIS (p < 0.001). There was no difference between T11-midline and L1-midline for participants with SCI (p = 0.245). Spinally evoked motor response thresholds were ~13% lower during trains of stimulation compared to single pulses in non-SCI participants (p < 0.001), but not in participants with SCI (p = 0.101). With trains of stimulation, threshold intensities were slightly lower and the incidence of sEMR was considerably lower. Overall, stimulation threshold intensities were generally lower with the L1-midline electrode configuration and is therefore preferred. While single-pulse threshold intensities may overestimate threshold intensities for therapeutic TSS, tolerance to trains of stimulation will be the limiting factor in most cases.

MRI-based Measurement of Effects of Strength Training on Intramuscular Fat in People with and without Spinal Cord Injury.

INTRODUCTION: The accurate quantification of the proportion of fat in human muscles could help monitor disease status and test effectiveness of interventions in people with neurological conditions whose skeletal muscles are frequently infiltrated with fat. METHODS: We compared two commonly used magnetic resonance imaging methods to quantify fat in muscles. Measurements were obtained before and after 6 or 8 wk of strength training in a total of 116 muscles spanning the range of intramuscular fat proportions observed in able-bodied young adults and people with spinal cord injury. RESULTS: We successfully measured fat proportions in all muscles using the mDixon method but were unable to obtain plausible measurements with the T1-weighted method from muscles of able-bodied individuals or from the leaner 23% of muscles of people with spinal cord injury (muscles with less than approximately 8% fat). In muscles with more fat, measurements obtained with the two methods agreed well (intraclass correlation coefficient, 0.88; mean absolute difference, 5%). We also found that, compared with the T1-weighted method, the mDixon method provides a more detailed characterization of fat infiltration in muscle and a less variable measurement of the effect of training on the proportion of fat. The mDixon method showed that 6 or 8 wk of strength training did not appreciably change the proportion of intramuscular fat in either people with spinal cord injury or able-bodied people. CONCLUSION: On the basis of these findings, we recommend the use of mDixon methods in preference to T1-weighted methods to determine the effectiveness of interventions aimed at reducing intramuscular fat.