Effectiveness of Abdominal Functional Electrical Stimulation for Improving Bowel Function in People With a Spinal Cord Injury: A Study Protocol for a Double-Blinded Randomized Placebo-Controlled Clinical Trial.

Background: People with a spinal cord injury (SCI) have a high rate of bowel-related morbidity, even compared with people with other neurological disorders. These complications lower quality of life and place a financial burden on the health system. A noninvasive intervention that improves the bowel function of people with an SCI should reduce morbidity, improve quality of life, and lead to cost savings for health care providers. Objectives: To investigate the effectiveness of noninvasive abdominal functional electrical stimulation (FES) for improving bowel function in people with a chronic SCI. Methods: A prospective, double-blinded, 1:1 randomized, placebo-controlled intervention trial will be conducted with 80 adults with chronic SCI (>12 months since injury) above T8 single neurological level. The intervention will be a 45-minute abdominal FES (or placebo) session, 3 days per week, for 6 weeks. Main Study Parameters/Endpoints: Primary endpoint is whole gut transit time before and after 6 weeks of abdominal FES. Secondary endpoints measured before and after 6 weeks of abdominal FES are (1) colonic transit time; (2) quality of life (EQ-5D-5L); (3) participant-reported bowel function (International SCI Bowel Function Basic Data Set Questionnaire and visual analogue scale); (4) respiratory function (forced vital capacity, forced expiratory volume in 1 second, peak expiratory flow, maximal inspiratory pressure, and maximal expiratory pressure); (5) bladder symptoms (Neurogenic Bladder Symptom Score); (6) daily bowel management diary; and (7) unplanned hospital visits. Conclusion: Safety data will be collected, and a cost utility analysis using quality of life scores will be performed. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000386831.

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.

High nasal resistance is stable over time but poorly perceived in people with tetraplegia and obstructive sleep apnoea.

Obstructive sleep apnoea (OSA) is highly prevalent in people with tetraplegia. Nasal congestion, a risk factor for OSA, is common in people with tetraplegia. The purpose of this study was to quantify objective and perceived nasal resistance and its stability over four separate days in people with tetraplegia and OSA (n=8) compared to able-bodied controls (n=6). Awake nasal resistance was quantified using gold standard choanal pressure recordings (days 1 and 4) and anterior rhinomanometry (all visits). Nasal resistance (choanal pressure) was higher in people with tetraplegia versus controls (5.3[6.5] vs. 2.1[2.4] cmH2O/L/s, p=0.02) yet perceived nasal congestion (modified Borg score) was similar (0.5[1.8] vs. 0.5[2.0], p=0.8). Nasal resistance was stable over time in both groups (CV=0.23±0.09 vs. 0.16±0.08, p=0.2). These findings are consistent with autonomic dysfunction in tetraplegia and adaptation of perception to high nasal resistance. Nasal resistance may be an important therapeutic target for OSA in this population but self-assessment cannot reliably identify those most at risk.

Electrical stimulation of abdominal muscles to produce cough in spinal cord injury: effect of stimulus intensity.

BACKGROUND: Surface electrical stimulation of the abdominal muscles, with electrodes placed in the posterolateral position, combined with a voluntary cough can assist clearance of airway secretions in individuals with high-level spinal cord injury (SCI). OBJECTIVE: To determine whether an increase in stimulus intensity of the trains of electrical stimuli delivered to the expiratory muscles has an increasing effect on a stimulated voluntary cough and to determine at which stimulus intensity a plateau of cough peak expiratory flow occurs. METHODS: In 7 healthy individuals with a SCI at and above C7, gastric pressure (P(ga)), esophageal pressure (P(es)), peak expiratory cough flow (PEF(cough)), and expiratory volume were measured as participants coughed voluntarily with simultaneous trains of electrical stimuli delivered over the abdominal muscles (50 Hz, 1-s duration). The intensity of the stimulation was increased incrementally. RESULTS: A plateau in PEF(cough) occurred in all 7 individuals at a mean of 211 ± 29 mA (range 120-360 mA). Peak values reached for P(ga), P(es), and PEF(cough) were 83.0 ± 8.0 cm H2O, 66.1 ± 5.6 cm H2O, and 4.0 ± 0.4 l/s respectively. CONCLUSIONS: The plateau in expiratory cough flow that was associated with increasing expiratory pressures is indicative of dynamic airway compression. This suggests that the evoked cough will be effective in creating more turbulent airflow to further assist in dislodging mucus and secretions.

Abdominal muscle training can enhance cough after spinal cord injury.

BACKGROUND: Respiratory complications in people with high-level spinal cord injury (SCI) are a major cause of morbidity and mortality, particularly because of a reduced ability to cough as a result of abdominal muscle paralysis. OBJECTIVE: . We investigated the effect of cough training combined with functional electrical stimulation (FES) over the abdominal muscles for 6 weeks to observe whether training could improve cough strength. METHODS: Fifteen SCI subjects (C4-T5) trained for 6 weeks, 5 days per week (5 sets of 10 coughs per day) in a randomized crossover design study. Subjects coughed voluntarily at the same time as a train of electrical stimulation was delivered over the abdominal muscles via posterolaterally positioned electrodes (50 Hz, 3 seconds). Measurements were made of esophageal (Pes) and gastric (Pga) expiratory pressures and the peak expiratory flow (PEFcough) produced at the 3 time points of before, during, and after the training. RESULTS: During voluntary coughs, FES cough stimulation improved Pga, Pes, and PEFcough acutely, 20-fold, 4-fold, and 50%, respectively. Six weeks of cough training significantly increased Pga (37.1 ± 2.0 to 46.5 ± 2.9 cm H2O), Pes (35.4 ± 2.7 to 48.1 ± 2.9 cm H2O), and PEFcough (3.1 ± 0.1 to 3.6 ± 0.1 L/s). Cough training also improved pressures and flow during voluntary unstimulated coughs. CONCLUSIONS: FES of abdominal muscles acutely increases mechanical output in coughing in high-level SCI subjects. Six weeks of cough training further increases gastric and esophageal cough pressures and expiratory cough flow during stimulated cough maneuvers.

Respiratory care of patients with cervical spinal cord injury: a review.

Respiratory complications following cervical spinal cord injury are common and are the leading cause of morbidity and mortality after this type of injury. Impaired mechanics of ventilation, poor cough, increased secretions and bronchospasm predispose to atelectasis, pneumonia and exacerbations of respiratory failure. Prolonged mechanical ventilation and tracheostomy are often required. This review discusses the relevant pathophysiology, various ventilatory strategies and timing of tracheostomy, and examines the evidence surrounding physiotherapeutic and pharmacological treatment options.

Posterolateral surface electrical stimulation of abdominal expiratory muscles to enhance cough in spinal cord injury.

BACKGROUND: Spinal cord injury (SCI) patients have respiratory complications because of abdominal muscle weakness and paralysis, which impair the ability to cough. OBJECTIVE: This study aims to enhance cough in high-level SCI subjects (n = 11, SCI at or above T6) using surface electrical stimulation of the abdominal muscles via 2 pairs of posterolaterally placed electrodes. METHODS: From total lung capacity, subjects performed maximum expiratory pressure (MEP) efforts against a closed airway and voluntary cough efforts. Both efforts were performed with and without superimposed trains of electrical stimulation (50 Hz, 1 second) at a submaximal intensity set to evoke a gastric pressure (P(ga)) of 40 cm H(2)O at functional residual capacity. RESULTS: In the MEP effort, stimulation increased the maximal P(ga) (from 21.4 ± 7.0 to 59.0 ± 5.7 cm H(2)O) and esophageal pressure (P(es); 47.2 ± 11.7 to 65.6 ± 13.6 cm H(2)O). During the cough efforts, stimulation increased P(ga) (19.5 ± 6.0 to 57.9 ± 7.0 cm H(2)O) and P(es) (31.2 ± 8.7 to 56.6 ± 10.5 cm H(2)O). The increased expiratory pressures during cough efforts with stimulation increased peak expiratory flow (PEF, by 36% ± 5%), mean expiratory flow (by 80% ± 8%), and expired lung volume (by 41% ± 16%). In every subject, superimposed electrical stimulation improved peak expiratory flow during cough efforts (by 0.99 ± 0.12 L/s; range, 0.41-1.80 L/s). Wearing an abdominal binder did not improve stimulated cough flows or pressures. CONCLUSIONS: The increases in P(ga) and PEF with electrical stimulation using the novel posterolateral electrode placement are 2 to 3 times greater than improvements reported in other studies. This suggests that posterolateral electrical stimulation of abdominal muscles is a simple noninvasive way to enhance cough in individuals with SCI.

Effect on falls of providing single lens distance vision glasses to multifocal glasses wearers: VISIBLE randomised controlled trial.

OBJECTIVE: To determine whether the provision of single lens distance glasses to older wearers of multifocal glasses reduces falls. DESIGN: Parallel randomised controlled trial stratified by recruitment site and source of referral, with 13 months' follow-up and outcome assessors blinded to group allocation. SETTING: Community recruitment and treatment room assessments in Sydney and Illawarra regions of NSW, Australia. PARTICIPANTS: 606 regular wearers of multifocal glasses (mean age 80 (SD 7) years). Inclusion criteria included increased risk of falls (fall in previous year or timed up and go test >15 seconds) and outdoor use of multifocal glasses at least three times a week. INTERVENTIONS: Provision of single lens distance glasses with recommendations for wearing them for walking and outdoor activities compared with usual care. MAIN OUTCOME MEASURES: Number of falls and injuries resulting from falls during follow-up. RESULTS: Single lens glasses were provided to 275 (90%) of the 305 intervention group participants within two months; 162 (54%) of the intervention group reported satisfactory use of distance glasses for walking and outdoor activities for at least 7/12 months after dispensing. In the 299 intervention and 298 control participants available to follow-up, the intervention resulted in an 8% reduction in falls (incidence rate ratio 0.92, 95% confidence interval 0.73 to 1.16). Pre-planned sub-group analyses showed that the intervention was effective in significantly reducing all falls (incidence rate ratio 0.60, 0.42 to 0.87), outside falls, and injurious falls in people who regularly took part in outside activities. A significant increase in outside falls occurred in people in the intervention group who took part in little outside activity. CONCLUSIONS: With appropriate counselling, provision of single lens glasses for older wearers of multifocal glasses who take part in regular outdoor activities is an effective falls prevention strategy. The intervention may be harmful, however, in multifocal glasses wearers with low levels of outdoor activity. TRIAL REGISTRATION: Clinical trials NCT00350389.

Preventing falls in older multifocal glasses wearers by providing single-lens distance glasses: the protocol for the VISIBLE randomised controlled trial.

BACKGROUND: Recent research has shown that wearing multifocal glasses increases the risk of trips and falls in older people. The aim of this study is to determine whether the provision of single-lens distance glasses to older multifocal glasses wearers, with recommendations for wearing them for walking and outdoor activities, can prevent falls. We will also measure the effect of the intervention on health status, lifestyle activities and fear of falling, as well as the extent of adherence to the program. METHODS/DESIGN: Approximately 580 older people who are regular wearers of multifocal glasses people will be recruited. Participants will be randomly allocated to either an intervention group (provision of single lens glasses, with counselling and advice about appropriate use) or a control group (usual care). The primary outcome measure will be falls (measured with 13 monthly calendars). Secondary measures will be quality of life, falls efficacy, physical activity levels and adverse events. DISCUSSIONS: The study will determine the impact of providing single-lens glasses, with advice about appropriate use, on preventing falls in older regular wearers of multifocal glasses. This pragmatic intervention, if found to be effective, will guide practitioners with regard to recommending appropriate glasses for minimising the risk of falls in older people. TRIAL REGISTRATION: The protocol for this study was registered with the Clinical Trials.gov Protocol Registration System on June 7th 2006 (#350855).

Surface functional electrical stimulation of the abdominal muscles to enhance cough and assist tracheostomy decannulation after high-level spinal cord injury.

OBJECTIVE: Evaluation of noninvasive stimulation modalities to augment cough and assist tracheostomy decannulation in high-level tetraplegia. STUDY DESIGN: Single case study. METHODS: A 65-year-old man with C4 ASIA C tetraplegia had delayed rehabilitation due to a tracheostomy and recurrent pneumonia primarily resulting from ineffective cough. Anterior surface electrical stimulation (SES) of the abdominal musculature was conducted to train an effective cough and enable decannulation. Training occurred daily for 4 weeks. The patient was tested 1 year later with posterolateral SES to determine the relative clinical effect of this delivery method. RESULTS: At baseline, the addition of anterior SES increased maximal expiratory pressure (80%), maximal expiratory cough pressure (67%), and peak expiratory flow rate (11%). Three weeks after training began, the patient was decannulated following a program of SES and assisted and voluntary coughing. Upon testing 1 year later, SES with posterolaterally placed electrodes also produced an enhancement of voluntary cough attempts. CONCLUSIONS: Noninvasive SES can potentially assist decannulation of tracheostomies.

Health status rated with the Medical Outcomes Study 36-Item Short-Form Health Survey after spinal cord injury.

OBJECTIVE: To describe the health status of Australians with spinal cord injury (SCI). DESIGN: Survey. SETTING: Australian population-based sample. PARTICIPANTS: Participants (N=305) with SCI at recruitment to a randomized trial. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) health questionnaire. RESULTS: Compared with the general population, our sample reported significantly lower scores in 6 SF-36 domains (physical function, role-physical, bodily pain, general health, social function, vitality) and the physical component summary (PCS) score, but unexpectedly higher mental component summary (MCS) scores (difference in mean MCS scores, 4.6; 95% confidence interval [CI], 2.4-6.8). Compared with people with tetraplegia, those with paraplegia had better physical function and PCS scores (difference, 21; 95% CI, 17-24; difference, 3; 95% CI, 1-5, respectively), and worse bodily pain scores (difference, 9; 95% CI, 2-15). Recent urinary infections were associated with worse general health, vitality, mental health, and MCS scores. Receiving family or external physical care was associated with worse physical function and PCS scores, but better mental health and MCS scores. Older age at injury was associated with lower bodily pain and PCS scores. CONCLUSIONS: Using the SF-36, Australians with SCI rate their physical (not mental) health status as worse than the general population.