Clinical effectiveness of the sequential 4-channel NMES compared with that of the conventional 2-channel NMES for the treatment of dysphagia in a prospective double-blind randomized controlled study

Background To date, conventional swallowing therapies and 2-channel neuromuscular electrical stimulation (NMES) are standard treatments for dysphagia. The precise mechanism of 2-channel NMES treatment has not been determined, and there are controversies regarding the efficacy of this therapy. The sequential 4-channel NMES was recently developed and its action is based on the normal contractile sequence of swallowing-related muscles. Objective To evaluate and compare the rehabilitative effectiveness of the sequential 4-channel NMES with that of conventional 2-channel NMES. Methods In this prospective randomized case–control study, 26 subjects with dysphagia were enrolled. All participants received 2- or 4-channel NMES for 2–3weeks (minimal session: 7 times, treatment duration: 300–800min). Twelve subjects in the 4-channel NMES group and eleven subjects in the 2-channel NMES group completed the intervention. Initial and follow-up evaluations were performed using the videofluoroscopic dysphagia scale (VDS), the penetration-aspiration scale (PAS), the MD Anderson dysphagia inventory (MDADI), the functional oral intake scale (FOIS), and the Likert scale. Results The sequential 4-channel NMES group experienced significant improvement in their VDS (oral, pharyngeal, and total), PAS, FOIS, and MDADI (emotional, functional, and physical subsets) scores, based on their pretreatment data. VDS (oral, pharyngeal, and total) and MDADI (emotional and physical subsets) scores, but not PAS and FOIS scores, significantly improved in the 2-channel NMES group posttreatment. When the two groups were directly compared, the 4-channel NMES group showed significant improvement in oral and total VDS scores. Conclusions The sequential 4-channel NMES, through its activation of the suprahyoid and thyrohyoid muscles, and other infrahyoid muscles mimicking physiological activation, may be a new effective treatment for dysphagia. Trial registration: clinicaltrial.gov, registration number: NCT03670498, registered 13 September 2018, https://clinicaltrials.gov/ct2/show/NCT03670498?term=NCT03670498&draw=2&rank=1 .This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (Grant Number: HI18C1169). This research was supported by Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Min‑ istry of Science, ICT and Future Planning (NRF- NRF-2016R1D1A1B03935130)

Application of Automatic Kinematic Analysis Program for the Evaluation of Dysphagia in ALS patients

Dysphagia in amyotrophic lateral sclerosis (ALS) increases the risk of malnutrition, dehydration, and aspiration pneumonia. Kinematic analysis of videofluoroscopic swallowing study (VFSS) can provide detailed movement of the hyoid bone, revealing abnormalities of swallowing in ALS patients. We developed an automated kinematic analysis program (AKAP) that analyzes the trajectory of the hyoid bone via a visual tracking method. The aim of this study was to investigate the hyoid movement in ALS patients using AKAP and compare it with non-dysphagic subjects. Thirty ALS patients who underwent VFSS in Seoul National University Bundang Hospital between 2015 and 2017 were recruited. For comparison, 30 age-matched control subjects were also enrolled; the same swallowing study was conducted using thin fluid and yogurt. The hyoid bone movement was analyzed by evaluating the vertical and horizontal distances with four peak points (A, B, C, D), and the time of each point were also calculated. With respect to distance parameters, only vertical peak distance (distance between B, D points) during thin fluid swallowing was significantly decreased in ALS patients. (p = 0.038) With respect to temporal parameters, Time ABC, Time ABCD, and Duration C were significantly increased in ALS patients when swallowing both thin fluid and yogurt. (Time ABC p = 0.019, p = 0.002; Time ABCD p = 0.001, p = 0.004; Duration C p = 0.004, p = 0.025 respectively). This result revealed that dysphagia in ALS patient is caused by decreased velocity of hyoid bone movement due to the development of weakness in swallowing-related muscles. The parameters of kinematic analysis could be used to quantitatively evaluate dysphagia in motor neuron disease.Y

The Mechanism of Hip Dislocation Related to the Use of Abduction Bar and Hip Compression Bandage in Patients With Spastic Cerebral Palsy

Objective The aims of the study were to identify the differences of forces in the hip adductors between with or without the abduction bar and to evaluate the effect of hip compression bandage on the spasticity of the adductor muscles. Design Thirty-three patients with cerebral palsy (Gross Motor Functional Classification System IV and V) were prospectively included. Surface electromyography was taken by attaching electromyography on the adductor and abductor muscles. Theraband was used as hip compression bandage. Surface electromyography were taken when spasticity provoked with and without abduction bar, as well as with both abduction bar and hip compression bandage. Root mean square values were measured. Results Root mean square values were significantly increased with abduction bar in the adductor longus, adductor magnus, and tensor fascia lata muscles. Adductor Sum and Net Adduction Index showed significant increases after the use of abduction bar. After applying hip compression bandage, the Net Adduction Index was significantly decreased. Conclusions Our results showed significant changes in the adductor muscles' amplitude, Adduction Sum, and Net Adduction Index. These results indicate that forces that worsen hip dislocation may develop, and therefore, abduction bar should either not be used for spastic cerebral palsy patients or should only be used with hip compression wrapping in place as well.N

Compensatory Effects of Sequential 4-Channel Neuromuscular Electrical Stimulation for the Treatment of Acute, Subacute, and Chronic Dysphagia in a Prospective, Double-Blinded Randomized Clinical Trial

Background. The precise mechanism of 2-channel neuromuscular electrical stimulation (NMES) treatment is unknown, and controversy remains over its efficacy. The sequential 4-channel NMES was newly developed based on normal contractile sequences of swallowing-related muscles. Objective. To assess the clinical efficacy of sequential 4-channel NMES during swallowing. Methods. In this prospective RCT, 52 inpatients with dysphagia (acute, subacute, and chronic state) after stroke, brain tumor, or encephalitis were enrolled. Participants who underwent a videofluoroscopic swallowing study (VFSS) and clinical evaluation were enrolled and were randomly assigned to the 4-channel NMES or sham group. The 4-channel NMES and sham groups swallowed thin and honey-like fluids under NMES (sequential stimulation on suprahyoid and infrahyoid) and sham stimulation, respectively. The procedures were evaluated with the VFSS. Pre- and post-treatment evaluations were performed with the videofluoroscopic dysphagia scale (VDS), penetration-aspiration scale (PAS), Likert scale, and kinematic analysis. Results. The 4-channel NMES group showed significantly greater improvements than the sham group with respect to oral VDS, pharyngeal VDS, total VDS, and PAS (P < .05). Furthermore, the Likert scale for satisfaction, easiness, and discomfort for swallowing showed favorable results for the 4-channel NMES group (P < .05). In the kinematic analysis, the peak speed point, distance, and velocity of hyoid movement were significantly greater in the 4-channel NMES group (P < .05). Conclusions. Sequential 4-channel NMES activating the suprahyoid, thyrohyoid, and other infrahyoid muscles during swallowing showed significant clinical improvement with respect to VDS, PAS, and kinematic analysis. Therefore, sequential 4-channel NMES is a potential new functional electrical stimulation system for the treatment of dysphagia.N

Efficacy of a Hip Brace for Hip Displacement in Children With Cerebral Palsy A Randomized Clinical Trial

IMPORTANCE There is no consensus on interventions to slow the progress of hip displacement in patients with cerebral palsy. OBJECTIVE To investigate the efficacy of a novel hip brace in preventing progressive hip displacement in patients with cerebral palsy. DESIGN, SETTING, AND PARTICIPANTS This 2-group randomized clinical trial was conducted at 4 tertiary hospitals in South Korea from July 2019 to November 2021. Participants included children aged 1 to 10 years with nonambulatory cerebral palsy (Gross Motor Function Classification System level IV or V). Block randomization was used to assign an equal number of patients to the study and control groups via computerized random allocation sequences. Data were analyzed from November to December 2021. INTERVENTIONS The intervention group wore the hip brace for at least 12 hours a day for the study duration (ie, 12 months). Follow-up evaluations were performed after 6 and 12 months of wearing the brace. Both groups proceeded with conventional rehabilitation therapy during the trial. MAIN OUTCOMES AND MEASURES The primary outcome was the Reimers migration index (MI) on radiography, as assessed by 3 blinded investigators. Primary outcome variables were analyzed using linear mixed models. Secondary outcomes include change in the Caregiver Priorities & Child Health Index of Life with Disabilities, on which lower scores indicate better quality of life. RESULTS A total of 66 patients were included, with 33 patients (mean [SD] age, 68.7 [31.6] months; 25 [75.8%] boys) randomized to the intervention group and 33 patients (mean [SD] age, 60.7 [24.9] months; 20 [60.6%] boys) randomized to the control group. The baseline mean (SD) MI was 37.4% (19.3%) in the intervention group and 30.6% (16.3%) in the control group. The mean difference of the MI between the intervention group and control group was -8.7(95% CI, -10.2 to -7.1) percentage points at 6 months and -12.7 (95% CI, -14.7 to -10.7) percentage points at 12 months. The changes in the Caregiver Priorities & Child Health Index of Life with Disabilities were favorable in the study group and reached statistical significance at the 6-month follow-up compared with the control group (difference, -14.2; 95% CI, -25.2 to -3.3). CONCLUSIONS AND RELEVANCE In this randomized clinical trial, the novel hip brace was significantly effective in preventing the progression of hip displacement, compared with the control group. It effectively improved quality of life in patients with nonambulatory cerebral palsy. Therefore, hip brace use could be a promising treatment method to delay hip surgery and improve the quality of life of patients with nonambulatory cerebral palsy.Y