Trunk Inclination on Respiratory-swallowing Coordination

Study Overview
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Brief Summary
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Most caregivers do not know the influence of improper positioning therefore subjects suffer from possible choking risks. The aims of this study were to investigate the timing and coordination of swallowing and respiration in 4 different seat inclination angles, with liquid and bolus. A self-developed wearable device to measure the submandibular muscle surface EMG, the movement of thyroid cartilage and respiratory status of nasal cavity. This program could auto-analysis the onset and offset of duration, and the excursion and strength of thyroid cartilage will be calculated when it was moving, coordination between breathing and swallowing was also included. The results of this study would serve as the clinical guidelines for proper feeding positions for different populations and for different food contents.

Detailed Description
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Swallowing is not only an important function for life maintenance, but also for quality of life improvement. Statistics revealed that subjects with intellectual disability or multiple disabilities have problems in controlling muscle tone and maintaining posture. In such circumstances, these subjects experience problems during feeding or eating. The adjustment of seat inclination would help in feeding/eating process. However, the proper inclination angle should be evaluated by medical professionals, however, most caregivers do not know the influence of improper positioning therefore subjects suffer from possible choking risks. The aims of this study were to investigate the timing and coordination of swallowing and respiration in 4 different seat inclination angles, with liquid and bolus. In the first stage, the investigators intend to use a self-developed wearable device to measure the submandibular muscle surface EMG, the movement of thyroid cartilage and respiratory status of nasal cavity. This particular program could auto-analysis the onset and offset of duration, and the excursion and strength of thyroid cartilage will be calculated when it was moving, coordination between breathing and swallowing was also included. The measurement would be done in four seat inclination angles (5, 15, 30, 45) for each subject. The data collected between different conditions would be compared, and suggestions of ideal angles during swallowing would be made. The second stage is the design and development of a feedback-controlled seat angle adjustment device, based on the data collected. The results of this study would serve as the clinical guidelines for proper feeding positions for different populations and for different food contents. The ergonomic data would also provide references for assistive technology professionals and practitioners in device design and development.

Official Title
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Trunk Inclination Angle on Swallowing/Respiratory Function and the Development of Smart Positioning-angle Adjustment Device

Conditions
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Disabling Disease

Intervention / Treatment
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* Behavioral: angle of inclination
* Other: food type


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Typical-developed: 1. ages ranged from 20 to 60 years old, People with disabilities: ages ranged from 20 to 60 years old, usually a need for supplementary feeding. Exclusion criteria: Excluded conditions are cases of intubation and feeding, severely mentally retarded or autistic cases that cannot express comfort, cases of frequent choking, and those who have been treated with a throat tube and have a narrow throat. Exclude subjects who have undergone throat or nasal cavity surgery or have abnormalities in these two parts

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The measurement would be done in 4 seat inclination angles (5, 15, 30, 45) and for 3 different food types for each subject.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: angle 5 + 1ml water<br>The measurement would be done in seat inclination angles of 5 degrees with 1 ml water intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 5 + 5 ml water<br>The measurement would be done in seat inclination angles of 5 degrees with 5 ml water intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 5 + 5 ml pudding<br>The measurement would be done in seat inclination angles of 5 degrees with 5 ml pudding intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 15 + 1ml water<br>The measurement would be done in seat inclination angles of 15 degrees with 1 ml water intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 15 + 5 ml water<br>The measurement would be done in seat inclination angles of 15 degrees with 5 ml water intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 15 + 5 ml pudding<br>The measurement would be done in seat inclination angles of 15 degrees with 5 ml pudding intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 30 + 1ml water<br>The measurement would be done in seat inclination angles of 30 degrees with 1 ml water intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 30 + 5 ml water<br>The measurement would be done in seat inclination angles of 30 degrees with 5 ml water intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 30 + 5 ml pudding<br>The measurement would be done in seat inclination angles of 30 degrees with 5 ml pudding intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 45 + 1ml water<br>The measurement would be done in seat inclination angles of 45 degrees with 1 ml water intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 45 + 5 ml water<br>The measurement would be done in seat inclination angles of 45 degrees with 5 ml water intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|
| Active Comparator: angle 45 + 5 ml pudding<br>The measurement would be done in seat inclination angles of 45 degrees with 5 ml pudding intake. | Behavioral: angle of inclination<br>* The measurement would be done in seat inclination angles of 5,15,30,45 degrees.<br>Other: food type<br>* the swallowing was tested with 3 food types<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography | Two electrodes were attached to the submandibular muscle to register the electric potential generated by the muscles. | 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow. | 
| thyroid cartilage excursion | A force-sensing resistor (FSR) was fixed over the larynx at the thyroid cartilage position with an elastic belt to detect the cartilage excursion. | 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow. | 
| nasal airflow | A nasal airflow cannula was placed in front of the nasal cavity and was connected to a pressure transducer (Pro-Tech Services, Murrysville, PA, USA) to detect exhalation and inhalation. | 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensors, disability, positioning, swallowing, respiration, assistive device