Implanted Peroneal Nerve Stimulator Treatment for Drop Foot Caused by Central Nervous System Lesion: A Twelve-Month Follow-up of 21 Patients.

OBJECTIVE: Drop foot is a common impairment following stroke or other causes of central pathology. We report data on patient self-perceived performance, satisfaction with performance, walking ability, and adverse effects after surgical implantation of the ActiGait® drop foot stimulator. DESIGN: Prospective case study with a 12-month follow-up. SUBJECTS: Twenty-one participants with drop foot caused by central nervous system lesion. METHODS: The patients' self-perceived performance and satisfaction with performance were evaluated using the Canadian Occupational Performance Measure (COPM). Walking ability was assessed using a 10-m walk test and a 6-min walk. Nerve conduction of the peroneal nerve was examined in 10 patients. RESULTS: At follow-up, COPM self-percieved performance from 3.2 to 6.7 points, the median increase being 2.8 (interquartile range (IQR) 2.2-5.0), p < 0.001. Likewise, the COPM satisfaction with performance increased from 2.6 to 6.9 points, the median increase being 4.2 (IQR 2.8-5.8), p < 0.001. Walking velocity increased 0.1 m/s from a baseline measurement of 0.73 m/s (95% confidence interval (95% CI) 0.03-0.2), n = 21, p < 0.01, and walking distance increased by 33 m, from a baseline measurement of 236 m (95% CI 15-51), n = 21, p < 0.001. CONCLUSION: Stimulation of the peroneal nerve by an implantable stimulator increases self-perceived performance, satisfaction with performance, and ambulation in patients with long-lasting drop foot caused by a central nervous system lesion.

Black or white coffee before anaesthesia?: A randomised crossover trial.

BACKGROUND: In current preoperative fasting guidelines, coffee with milk is still regarded by many as solid food. Evidence on the consequences for gastric volume of adding milk to coffee 2 h before anaesthesia is still weak. OBJECTIVES: The aim of this study was to compare the gastric volume by MRI in healthy volunteers after drinking coffee with and without added milk. DESIGN: A randomised crossover trial where all participants were exposed to three coffee and milk mixtures performed as a noninferiority study with a predefined noninferiority limit of 12 ml. SETTING: Department of Day Surgery and Department of Radiology, Aarhus University Hospital, Aarhus, Denmark. The study was conducted between August 2013 and February 2014. PARTICIPANTS: Total 32 healthy volunteers, aged 18 to 71 years. INTERVENTIONS: The participants fasted for 6 h for solid food, and 2 h before the MRI examination of gastric volume, each participant ingested one of three coffee mixtures: 175 ml coffee, including either 0 or 20 or 50% full fat milk. Each participant was studied by MRI three times separated by a minimum time interval of 2 days. The order of coffee mixture ingested was determined by random allocation. MAIN OUTCOME MEASURE: Gastric volume as measured by MRI. RESULTS: The mean gastric volume for black coffee was 27.8 ml, for coffee with 20% milk 17.9 ml and for coffee with 50% milk 20.6 ml. Compared to black coffee, the gastric volume for 20% milk was significantly decreased with a difference of -10.0 ml (95% confidence interval, -18.2, -1.8), and for 50% milk it was insignificantly decreased, -7.2 ml (95% confidence interval, -17.4, +2.9). The upper confidence interval for the difference in gastric volume between the 'no milk added' group and each 'milk added' group did not reach the noninferiority limit of 12 ml. CONCLUSION: The study provides evidence that adding up to 50% full fat milk to coffee leads to no or only a minimal increase of the gastric volume 2 h later. The results support a liberalisation of policy on the addition of milk to hot drinks before planned anaesthesia. TRIAL REGISTRATION: www.Clinicaltrials.gov identifier: NCT02361632.

Patients' perceptions of the benefits and problems of using the ActiGait implanted drop-foot stimulator.

OBJECTIVE: To evaluate patients' perceptions of the benefits and problems associated with using the ActiGait implanted drop-foot stimulator. METHOD: Thirteen participants who had suffered a stroke at least 6 months prior to recruitment, had a drop-foot that affected walking and had taken part in a trial in which an ActiGait drop-foot stimulator had been implanted, completed a postal questionnaire. RESULTS: Users agreed that the ActiGait had a positive effect on walking; they used it regularly and had little difficulty with putting it on and taking it off. Reliability was a greater problem at 90 days than at the final assessment. Ten of the 13 responders either agreed or strongly agreed with the statement that the ActiGait improved their quality of life at 90 days and 9 out of 12 at the final assessment: 11 of the 12 respondents would recommend the ActiGait to others. DISCUSSION AND CONCLUSION: From the users' perspective the ActiGait improved walking, it was reported to be used regularly and it appeared to be easier to use than a surface system. Users were equivocal about the reliability of the system at 90 days, but at the final assessment reliability had improved.

Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia.

OBJECTIVE: To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety. DESIGN: A phase II trial in which a consecutive sample of participants acted as their own controls. SUBJECTS: People who had suffered a stroke at least 6 months prior to recruitment and had a drop-foot that affected walking were recruited from 3 rehabilitation centres in Denmark. METHODS: Stimulators were implanted into all participants. Outcome measures were range of ankle dorsiflexion with stimulation and maximum walking speed and distance walked in 4 minutes. Measurements were applied before implantation, at 90 days and at a long-term follow-up assessment. Changes over time and with and without stimulation are reported. Safety was evaluated by nerve conduction velocity and adverse events. RESULTS: Fifteen participants were implanted and 13 completed the trial. Long-term improvements were detected in walking speed and distance walked in 4 minutes when stimulated, and the orthotic effect of stimulation showed statistically significant improvement. The device did not compromise nerve conduction velocity and no serious device-related adverse events were reported. Technical problems were resolved by the long-term follow-up assessment at which further improvement in walking was observed. CONCLUSION: This trial has evaluated the safety and performance of the device, which was well accepted by patients and did not compromise safety.