Oral neuromuscular training in patients with dysphagia after stroke: a prospective, randomized, open-label study with blinded evaluators.

BACKGROUND: Oral and pharyngeal swallowing dysfunction are common complications in acute stroke patients. This primary aim of this study was to determine whether oral neuromuscular training improves swallowing function in participants with swallowing dysfunction after stroke. A secondary aim was to assess how well results of the timed water-swallow test (TWST) correspond with swallowing dysfunction diagnosed by videofluoroscopy (VFS). METHODS: This was an intention-to-treat two-centre prospective randomized open-label study with blinded-evaluators (PROBE) design. At 4 weeks after stroke onset, participants with swallowing dysfunction were randomized to 5 weeks of continued orofacial sensory-vibration stimulation with an electric toothbrush or additional oral neuromuscular training with an oral device (Muppy®). Participants were examined with TWST, a lip-force test, and VFS before (baseline), after 5 weeks' treatment (the end-of-treatment), and 12 months after treatment (follow-up). The baseline VFS results were compared with the TWST results. The primary endpoint was changes in swallowing rate assessed using TWST, from baseline to the end of training and from baseline to follow-up based on intention-to-treat analyses. The secondary endpoint was the corresponding changes in lip-force between baseline, the end of treatment, and follow-up. RESULTS: The participants were randomly assigned as controls (n = 20) or for intervention with oral neuromuscular training (n = 20). After treatment, both groups had improved significantly (intervention, P < 0.001; controls, P = 0.001) in TWST but there was no significant between-group difference in swallowing rate. At the 12-month follow-up, the intervention group had improved further whereas the controls had deteriorated, and there were significant between-group differences in swallowing rate (P = 0.032) and lip force (P = 0.001). A TWST < 10 mL/sec at baseline corresponded to VFS-verified swallowing dysfunction in all assessed participants. CONCLUSION: The 5-week oral neuromuscular training improved swallowing function in participants with post-stroke dysphagia compared with the controls 12 months after intervention, but there was no between-group difference in improvement immediately after treatment. TWST results corresponded with VFS results, making TWST a feasible method for identifying persons with swallowing dysfunction after stroke. Larger randomized controlled trials are required to confirm our preliminary positive long-term results. TRIAL REGISTRATION: Retrospectively registered at ClinicalTrials.gov : NCT04164420 . Registered on 15 November 2019.

Effects of oral neuromuscular training on swallowing dysfunction among older people in intermediate care-a cluster randomised, controlled trial.

OBJECTIVES: this prospective, cluster randomised, controlled trial investigated the effect of oral neuromuscular training among older people in intermediate care with impaired swallowing. METHODS: older people (≥65 years) with swallowing dysfunction were cluster randomised according to care units for 5 weeks of neuromuscular training of the orofacial and pharyngeal muscles or usual care. The primary endpoint was the change in swallowing rate (assessed with a timed water swallow test) from baseline to the end-of-treatment and 6 months post-treatment. The secondary endpoints were changes in signs of aspiration during the water swallow test, and swallowing-related quality of life (QOL). An intention-to-treat principle was followed, and mixed-effects models were used for data analysis with the clustered study design as a random factor. RESULTS: in total, 385 participants from 36 intermediate care units were screened, and 116 participants were randomly assigned to oral neuromuscular training (intervention; n = 49) or usual care (controls; n = 67). At the end of treatment, the geometric mean of the swallowing rate in the intervention group had significantly improved 60% more than that of controls (P = 0.007). At 6 months post-treatment, the swallowing rate of the intervention group remained significantly better (P = 0.031). Signs of aspiration also significantly reduced in the intervention group compared with controls (P = 0.01). No significant between-group differences were found for swallowing-related QOL. CONCLUSIONS: oral neuromuscular training is a new promising swallowing rehabilitation method among older people in intermediate care with impaired swallowing. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02825927.

Swallowing dysfunction as risk factor for undernutrition in older people admitted to Swedish short-term care: a cross-sectional study.

BACKGROUND: Swallowing dysfunction and risk of undernutrition increase the risk of pneumonia, morbidity, and mortality. Short-term care is an unexplored care context, where many older people stay yearly. AIM: This cross-sectional study aimed to describe and analyze the relationship between swallowing dysfunction and risk of undernutrition among older people in short-term care, including potential gender-related differences. METHODS: In total, 391 people (209 women), aged ≥ 65 years (median age 84 years) and admitted to short-term care in five Swedish counties participated. They went through a timed water swallow test to assess swallowing dysfunction, including abnormal swallowing capacity and signs of aspiration (i.e., cough and voice change). Risk for undernutrition was assessed using the Minimal Eating Observation and Nutrition Form-version II. RESULTS: Swallowing dysfunction was observed in 248 of 385 (63%) participants, including abnormal swallowing capacity in 213 of 385 (55%) and aspiration signs in 127 of 377 (34%). Abnormal swallowing capacity was more frequent among women (p = 0.030), whereas men with normal swallowing capacity exhibited signs of aspiration more frequently (cough p = 0.038, voice change p = 0.004). Risk of undernutrition was found in 91 of 390 (23%) participants, more frequently among women (p = 0.007). A logistic regression model revealed an increased risk of undernutrition among older people with abnormal swallowing capacity (OR 1.74, 95% CI 1.04-2.92, p = 0.034). CONCLUSIONS: The high prevalence of swallowing dysfunction and risk of undernutrition highlight the need for a systematic screening program and feasible treatment to improve swallowing function for adequate and safe food intake among older people in short-term care. CLINICAL TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov on July 4, 2016, under NCT02825927.

Oral neuromuscular training relieves hernia-related dysphagia and GERD symptoms as effectively in obese as in non-obese patients.

BACKGROUND: Many physicians insist patients lose weight before their hiatal hernia (HH) condition and related symptoms including intermittent esophageal dysphagia (IED) and gastroesophageal reflux disease (GERD) can be treated, but it is not proven that body mass index (BMI) has an impact on exercise-based treatment of HH-related symptoms. AIMS/OBJECTIVES: To investigate whether BMI has significance on IQoro® neuromuscular training (IQNT) effectiveness in treating HH-related symptoms. MATERIAL AND METHODS: Eighty-six patients with sliding HH and enduring IED and GERD symptoms, despite proton pump inhibitor medication, were consecutively referred for 6 months' IQNT comprising 11/2 minutes daily. They were grouped by BMI which was recorded before and after IQNT, as were their symptoms of IED, reflux, heartburn, chest pain, globus sensation, non-productive cough, hoarseness, and misdirected swallowing. They were also assessed on food swallowing ability, water swallowing capacity and lip force both before and after treatment. RESULTS: After IQNT, all BMI groups showed significant improvement (p < .001) of all assessments' and symptoms; and heartburn, cough and misdirected swallowing were significantly more reduced in the severely obese. CONCLUSIONS AND SIGNIFICANCE: IQNT can treat HH-related IED and GERD symptoms as successfully in moderately or severely obese patients as in those with normal bodyweight.

Study protocol for the SOFIA project: Swallowing function, Oral health, and Food Intake in old Age: a descriptive study with a cluster randomized trial.

BACKGROUND: Extensive studies have shown that older people are negatively impacted by impaired eating and nutrition. The abilities to eat, enjoy food, and participate in social activities associated with meals are important aspects of health-related quality of life (HRQoL) and recovery after illness. This project aims to (i) describe and analyze relationships between oral health and oral HRQoL, swallowing ability, eating ability, and nutritional risk among older individuals admitted to short-term care; (ii) compare the perceptions that older individuals and staff report on care quality related to oral hygiene and eating; and (iii) study the feasibility and effects of a training program for people with impaired swallowing (i.e., dysphagia). METHODS/DESIGN: This project consists of two parts, which will be performed in five Swedish counties. It will include approximately 400 older individuals and 200 healthcare professionals. Part 1 is a cross-sectional, descriptive study of older people admitted to short-term care. Subjects will be assessed by trained professionals regarding oral health status, oral HRQoL, eating and nutritional risk, and swallowing ability. Swallowing ability will be measured with a teaspoon test and a swallowing capacity test (SCT). Furthermore, subjects and staff will complete a questionnaire regarding their perceptions of care quality. Part 2 is a cluster randomized intervention trial with controls. Older participants with dysphagia (i.e., SCT <10 ml/s, measured in part 1) will be recruited consecutively to either the intervention or control group, depending on where they were admitted for short-term care. At baseline, all subjects will be assessed for oral health status, oral HRQoL, eating and nutritional risk, swallowing ability, and swallowing-related QoL. Then, the intervention group will receive 5 weeks of training with an oral screen for neuromuscular training focused on orofacial and pharyngeal muscles. After completing the intervention, and at six months post-intervention, all assessments will be repeated in both study groups. DISCUSSION: The results will make important contributions to rehabilitation knowledge, including approaches for improving swallowing function, oral health, and food intake and for improving the quality of oral care for older people. TRIAL REGISTRATION: This trial was retrospectively registered at ClinicalTrials.gov, on July 4, 2016, identifier: NCT02825927 .

Effect of IQoro® training on impaired postural control and oropharyngeal motor function in patients with dysphagia after stroke.

Conclusion All patients with dysphagia after stroke have impaired postural control. IQoro® screen (IQS) training gives a significant and lasting improvement of postural control running parallel with significant improvement of oropharyngeal motor dysfunction (OPMD). Objectives The present investigation aimed at studying the frequency of impaired postural control in patients with stroke-related dysphagia and if IQS training has any effect on impaired postural control in parallel with effect on OPMD. Method A prospective clinical study was carried out with 26 adult patients with stroke-related dysphagia. The training effect was compared between patients consecutively investigated at two different time periods, the first period with 15 patients included in the study more than half a year after stroke, the second period with 11 patients included within 1 month after stroke. Postural control tests and different oropharyngeal motor tests were performed before and after 3 months of oropharyngeal sensorimotor training with an IQS, and at a late follow-up (median 59 weeks after end of training). Result All patients had impaired postural control at baseline. Significant improvement in postural control and OPMD was observed after the completion of IQS training in both intervention groups. The improvements were still present at the late follow-up.

Esophageal dysphagia and reflux symptoms before and after oral IQoro(R) training.

AIM: To examine whether muscle training with an oral IQoro(R) screen (IQS) improves esophageal dysphagia and reflux symptoms. METHODS: A total of 43 adult patients (21 women and 22 men) were consecutively referred to a swallowing center for the treatment and investigation of long-lasting nonstenotic esophageal dysphagia. Hiatal hernia was confirmed by radiologic examination in 21 patients before enrollment in the study (group A; median age 52 years, range: 19-85 years). No hiatal hernia was detected by radiologic examination in the remaining 22 patients (group B; median age 57 years, range: 22-85 years). Before and after training with an oral IQS for 6-8 mo, the patients were evaluated using a symptom questionnaire (esophageal dysphagia and acid chest symptoms; score 0-3), visual analogue scale (ability to swallow food: score 0-100), lip force test (≥ 15 N), velopharyngeal closure test (≥ 10 s), orofacial motor tests, and an oral sensory test. Another twelve patients (median age 53 years, range: 22-68 years) with hiatal hernia were evaluated using oral IQS traction maneuvers with pressure recordings of the upper esophageal sphincter and hiatus canal as assessed by high-resolution manometry. RESULTS: Esophageal dysphagia was present in all 43 patients at entry, and 98% of patients showed improvement after IQS training [mean score (range): 2.5 (1-3) vs 0.9 (0-2), P < 0.001]. Symptoms of reflux were reported before training in 86% of the patients who showed improvement at follow-up [1.7 (0-3) vs 0.5 (0-2), P < 0.001). The visual analogue scale scores were classified as pathologic in all 43 patients, and 100% showed improvement after IQS training [71 (30-100) vs 22 (0-50), P < 0.001]. No significant difference in symptom frequency was found between groups A and B before or after IQS training. The lip force test [31 N (12-80 N) vs 54 N (27-116), P < 0.001] and velopharyngeal closure test values [28 s (5-74 s) vs 34 s (13-80 s), P < 0.001] were significantly higher after IQS training. The oral IQS traction results showed an increase in mean pressure in the diaphragmatic hiatus region from 0 mmHg at rest (range: 0-0 mmHG) to 65 mmHg (range: 20-100 mmHg). CONCLUSION: Oral IQS training can relieve/improve esophageal dysphagia and reflux symptoms in adults, likely due to improved hiatal competence.

Effect of IQoro(R) training in hiatal hernia patients with misdirected swallowing and esophageal retention symptoms.

CONCLUSION: Misdirected swallowing can be triggered by esophageal retention and hiatal incompetence. The results show that oral IQoro(R) screen (IQS) training improves misdirected swallowing, hoarseness, cough, esophageal retention, and globus symptoms in patients with hiatal hernia. OBJECTIVES: The present study investigated whether muscle training with an IQS influences symptoms of misdirected swallowing and esophageal retention in patients with hiatal hernia. METHODS: A total of 28 adult patients with hiatal hernia suffering from misdirected swallowing and esophageal retention symptoms for more than 1 year before entry to the study were evaluated before and after training with an IQS. The patients had to fill out a questionnaire regarding symptoms of misdirected swallowing, hoarseness, cough, esophageal retention, and suprasternal globus, which were scored from 0-3, and a VAS on the ability to swallow food. The effect of IQS traction on diaphragmatic hiatus (DH) pressure was recorded in 12 patients with hiatal hernia using high resolution manometry (HRM). RESULTS: Upon entry into the study, misdirected swallowing, globus sensation, and esophageal retention symptoms were present in all 28 patients, hoarseness in 79%, and cough in 86%. Significant improvement was found for all symptoms after oral IQS training (p < 0.001). Traction with an IQS resulted in a 65 mmHg increase in the mean HRM pressure of the DH.

Effect of oral IQoro R and palatal plate training in post-stroke, four-quadrant facial dysfunction and dysphagia: A comparison study.

CONCLUSION: Training with either a palatal plate (PP) or an oral IQoro(R) screen (IQS) in patients with longstanding facial dysfunction and dysphagia after stroke can significantly improve facial activity (FA) in all four facial quadrants as well as swallowing capacity (SC). Improvements remained at late follow-up. The training modalities did not significantly differ in ameliorating facial dysfunction and dysphagia in these patients. However, IQS training has practical and economic advantages over PP training. OBJECTIVES: This study compared PP and oral IQS training in terms of (i) effect on four-quadrant facial dysfunction and dysphagia after a first-ever stroke, and (ii) whether the training effect persisted at late follow-up. METHODS: Patients were included during two periods; 13 patients in 2005-2008 trained with a PP, while 18 patients in 2009-2012 trained with an IQS. Four-quadrant facial dysfunction was assessed with an FA test and swallowing dysfunction with a SC test: before and after a 3-month training period and at late follow-up. FA and SC significantly improved (p < 0.001) in both groups. FA test scores after training and at late follow-up did not differ significantly between the groups, irrespective of whether the interval between stroke incidence and the start of training was long or short.

Effects on facial dysfunction and swallowing capacity of intraoral stimulation early and late after stroke.

BACKGROUND: Most patients with post-stroke dysphagia are also affected by facial dysfunction in all four facial quadrants. Intraoral stimulation can successfully treat post-stroke dysphagia, but its effect on post-stroke facial dysfunction remains unknown. OBJECTIVE: This study aimed to investigate whether intraoral stimulation after stroke has simultaneous effects on facial dysfunction in the contralateral lower facial quadrant and in the other three facial quadrants, on lip force, and on dysphagia. METHODS: Thirty-one stroke patients were treated with intraoral stimulation and assessed with a facial activity test, lip force test, and swallowing capacity test at three time-points: before treatment, at the end of treatment, and at late follow-up (over one year after the end of treatment). RESULTS: Facial activity, lip force, and swallowing capacity scores were all improved between baseline and the end of treatment (P < 0.001 for each), with these improvements remaining at late follow-up. Baseline and treatment data did not significantly differ between patients treated short and late after stroke. CONCLUSIONS: Treatment with intraoral stimulation significantly improved post-stroke dysfunction in all four facial quadrants, swallowing capacity, and lip force even in cases of long-standing post-stroke dysfunction. Furthermore, such improvement remained for over one year after the end of treatment.

Four-quadrant facial function in dysphagic patients after stroke and in healthy controls.

This study aims to examine any motility disturbance in any quadrant of the face other than the quadrant innervated by the lower facial nerve contralateral to the cortical lesion after stroke. Thirty-one stroke-afflicted patients with subjective dysphagia, consecutively referred to a swallowing centre, were investigated with a facial activity test (FAT) in all four facial quadrants and with a swallowing capacity test (SCT). Fifteen healthy adult participants served as FAT controls. Sixteen patients were judged to have a central facial palsy (FP) according to the referring physician, but all 31 patients had a pathological FAT in the lower quadrant contralateral to the cortical lesion. Simultaneous pathology in all four quadrants was observed in 52% of stroke-afflicted patients with dysphagia; some pathology in the left or right upper quadrant was observed in 74%. Dysfunction in multiple facial quadrants was independent of the time interval between stroke and study inclusion. All patients except two had a pathological SCT. All the controls had normal activity in all facial quadrants. In summary the majority of poststroke patients with dysphagia have subclinical orofacial motor dysfunction in three or four facial quadrants as assessed with a FAT. However, whether subclinical orofacial motor dysfunction can be present in stroke-afflicted patients without dysphagia is unknown.

Influence of lip force on swallowing capacity in stroke patients and in healthy subjects.

CONCLUSION: In spite of no clinical signs of facial paresis, a pathological lip force (LF) will strongly influence swallowing capacity (SC). Stroke patients with impaired SC suffer a subclinical facial paresis. The results support earlier findings that LF training can be used to treat dysphagia. OBJECTIVES: Lip muscle training with an oral screen can improve both LF and SC in stroke patients, irrespective of the presence or absence of facial palsy. The aim was therefore to study the influence of LF on SC. METHODS: This prospective study included 22 stroke patients, aged 38­90 years, with dysphagia, 12 with initial unilateral facial paresis and 45 healthy subjects, aged 25­87 years. All were investigated with a Lip Force Meter (LF100), and with an SC test. RESULTS: A significant correlation was found between LF/SC (p = 0.012) in stroke patients but not in healthy subjects. LF/SC was not age-related in stroke patients. LF was not age-dependent in healthy subjects, but SC decreased with increasing age (p < 0.0001). However, SC did not reach a pathological value and a regression analysis showed that 73% of the variation in SC is attributable to LF and age.

Lip muscle training in stroke patients with dysphagia.

CONCLUSION: Training with an oral screen can improve lip force (LF) and swallowing capacity (SC) in stroke patients with oropharyngeal dysphagia, irrespective of the duration of pretreatment of dysphagia, and irrespective of the presence or absence of central facial paresis. It is more plausible that treatment results are attributable to sensory motor stimulation and the plasticity of the central nervous system than to the training of the lip muscles per se. OBJECTIVES: A close relationship has been demonstrated between LF and SC in stroke patients whether or not they are affected by facial paresis. It is not known how training of lip function can improve swallowing capacity. The present study was therefore designed to ascertain: (i) if training with an oral screen can improve the LF and SC of stroke patients with oropharyngeal dysphagia; to establish (ii) if improvement in LF and SC is connected with the presence or absence of central facial palsy, (iii) on the interval between stroke onset and initiation of treatment, (iv) on age, or (v) on sex. SUBJECTS AND METHODS: This was a retrospective study of 30 stroke patients, 49-88 years old, who were investigated with a Lip Force Meter, LF100 (LF100) and a swallowing capacity test (SCT) before and after a period of self-training lasting at least 5-8 weeks, using an oral screen. Initial central facial paresis was present in 24 patients. RESULTS: The median LF was 7 Newtons (N) (range 0-27) before treatment and 18.5 N (range 7-44) after treatment (p < 0.001). The median SC was 0 ml/s (range 0-9.1) before treatment and 12.1 ml/s (range 0-36.7) at follow-up (p < 0.001). There was no significant difference in swallowing improvement between patients with versus those without facial paresis. The interval between stroke attack and start of treatment, ranging from a few days up to 10 years, had no significant influence on the treatment results, nor did age or sex. The facial paresis was improved or at least ameliorated in all patients after the lip training period.

Reliable lip force measurement in healthy controls and in patients with stroke: a methodologic study.

A prefabricated oral screen has shown promising results as a muscle self-training device to improve the lip function of stroke patients affected by oropharyngeal dysphagia. However, a technique for the measurement of lip muscle force, whether in healthy individuals or in stroke patients, is lacking. The present study was designed to (1) test the intra- and interreliability of lip force measurements by means of a newly devised Lip Force Meter, LF100, (2) determine a normal lower limit for lip force in newtons (N), and (3) ascertain the instrument's sensitivity and specificity. LF100 is a modified strain gauge for recording the ability of lips to withstand pressure from a predentally placed oral screen. Forty-two healthy controls and 22 stroke patients agreed to participate in the trial. The controls and patients were examined three times with the LF100, with 2-min rest intervals, twice by investigator MH and once by investigator MO. Intrainvestigator reliability with the LF100 proved excellent in both controls and patients: ICC was 0.83 and 0.90, respectively. Interinvestigator reliability was good or excellent in both groups: ICC was 0.71 and 0.91. There was a significant difference in lip force between controls and stroke patients (mean = 24.7 +/- 6.3 N and 9.5 +/- 5.5 N, p < 0.001). The sensitivity of LF100 was 91% and the specificity 95%. The cutoff level for normal lip force was 15 N. The LF100 showed itself to be a suitable and reliable instrument for measuring lip force.

Effects of motor and sensory stimulation in stroke patients with long-lasting dysphagia.

Dysphagia is a common poststroke symptom with negative effects on recovery and rehabilitation. However, the orofacial regulation therapy, developed by Castillo Morales, comprising body regulation and orofacial regulation in combination with a palatal plate application has shown promising results in stroke patients. This therapy is based not only on muscle exercises but also on an improvement of the entire sensory-motor reflex arc involved in normal deglutition, and on the knowledge that the function of face and oropharynx at deglutition is closely interrelated with the entire body posture as well as with appropriate breathing. The treatment concept is relatively unknown to caregivers, partly due to lack of scientific evaluation of treatment results. The present investigation aimed to assess the effect of motor and sensory stimulation in stroke patients with dysphagia persisting for more than six months. Seven patients were evaluated with respect to orofacial and pharyngeal motility and sensory function before and two weeks after a five-week treatment period. The evaluation comprised a swallowing capacity test, a meal observation test, clinical examination of oral motor and sensory function, a velopharyngeal closure test, and videofluoroscopy. In addition, the symptoms were scored by the patients. An overall single-blind estimation showed objective and self-assessed swallowing improvement in all seven patients. Kappa coefficients are calculated on all reliability data, both inter- and intrarater reliabilities. Sensory and motor stimulation seems to be a promising therapy in stroke patients with long-lasting and persistent oropharyngeal dysphagia.