Effects of Biofeedback Training on Esophageal Peristalsis in Amyotrophic Lateral Sclerosis Patients with Dysphagia
Abstract
:1. Introduction
2. Materials and Methods
2.1. Subjects
- Age below 30 years and above 75 years;
- Significant deterioration of the swallowing function in the medical history and physical examination (a score of less than 5 points on the ALSSS scale);* ALSSS scale—ALS swallowing severity scale (Hillel, 1989)—10 point scale comprising a part of the ALSS scale (ALS severity scale) used to evaluate symptoms of swallowing in ALS patients.
- Deterioration of the clinical status of a patient during the course of the study (i.e., significant increase in bulbar symptoms, emergence of subjective respiratory dysfunction, cachexia, or intensification of limb symptoms making the patient unable to turn up for the study);
- FVC <50%, measured obligatorily by spirometry both in the seated and standing positions.
- Anatomical changes in the oral cavity, pharynx, or esophagus that prevent objective assessment;
- A swallowing disorder which is not the consequence of the primary disease (e.g., patients after surgical operations on neck, local radiotherapy, or other causes of esophageal peristalsis disturbance);
- Taking medication which negatively affect the motor functions of the esophagus (e.g., calcium blockers, beta blockers, nitrates);
- Comorbidities such as cardiovascular disease, especially cardiac arrythmia, as well as other digestive tract disorders;
- Lack of the patient’s consent to take part in the study.
- Neurological examination;
- Clinical evaluation of the severity of swallowing disturbance (ALSSS);
- Evaluation of dysphagia according to ALSSS scale;
- Evaluation of clinical condition according to semiquantitative scales such as Norris, ALS Functional Rating Scale Revised (ALSFRS-R) [10];
- Calculation of the body mass index (BMI).
2.2. Methods
- The measurement of maximal frequency of successful primary wet and dry swallows;
- The measurement of maximal frequency of successful primary swallows during the solid meal (the central part of bread without crust, with butter);
- The measurement of maximal frequency of successful primary swallows during liquid meals (blended juice).
2.3. Statistical Analysis
2.4. Sample Size Analysis and Power Estimation
- A 99% power to detect the difference of 30 in amplitude of a wet swallow, assuming mean 60 and SD 20 in the control group;
- A 99% power to detect the difference of 1 in duration of a wet swallow, assuming mean 2.5 and SD 0.7 in the control group;
- An 89% power to detect the difference of 0.5 in velocity of a wet swallow, assuming mean 2.5 and SD 0.5 in the control group;
- A 100% power to detect the difference of 40 in amplitude of a dry swallow, assuming mean 40 and SD 25 in the control group;
- An 89% power to detect the difference of 2 in duration of a dry swallow, assuming mean 2.5 and SD 2 in the control group;
- An 89% power to detect the difference of 0.5 in velocity of a dry swallow, assuming mean 4 and SD 0.5 in the control group.
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Groups | Age | Sex | WFN * Criteria | Duration of the Disease (Months) | Duration of Dysphagia (Months) |
---|---|---|---|---|---|
ALS subjects with dysphagia | 36–74 56.8 ± 11.4 (95%CI = 51.8–61.8) | Females n = 12 Males n = 8 | Definite ALS n = 7 (35%) Probable ALS n = 13 (65%) | 5–72 16.5 ± 14.9 (95%CI = 10.0–23.0) | 1–26 8.6 ± 6.4 (95%CI = 5.8–11.4) |
Control subjects | 35–65 48 ± 12.3 (95%CI = 42.6–53.4) | Females n = 9 Males n = 11 |
Group | Sex | Age (Years) | |
---|---|---|---|
Female | Male | x ± SD | |
ALS with dysphagia | 12 | 8 | 56.8 ± 11.4 (95%CI = 51.8–61.8) |
Control group | 9 | 11 | 48.0 ± 12.3 (95%CI = 42.6–53.4) |
Statistical significance, p value | 0.343 | 0.042 |
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Tomik, J.; Sowula, K.; Ceranowicz, P.; Dworak, M.; Stolcman, K. Effects of Biofeedback Training on Esophageal Peristalsis in Amyotrophic Lateral Sclerosis Patients with Dysphagia. J. Clin. Med. 2020, 9, 2314. https://doi.org/10.3390/jcm9072314
Tomik J, Sowula K, Ceranowicz P, Dworak M, Stolcman K. Effects of Biofeedback Training on Esophageal Peristalsis in Amyotrophic Lateral Sclerosis Patients with Dysphagia. Journal of Clinical Medicine. 2020; 9(7):2314. https://doi.org/10.3390/jcm9072314
Chicago/Turabian StyleTomik, Jerzy, Klaudia Sowula, Piotr Ceranowicz, Mateusz Dworak, and Kamila Stolcman. 2020. "Effects of Biofeedback Training on Esophageal Peristalsis in Amyotrophic Lateral Sclerosis Patients with Dysphagia" Journal of Clinical Medicine 9, no. 7: 2314. https://doi.org/10.3390/jcm9072314