An interventional study of angle of inclination and food type in Disabling Disease, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-03.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Supportive care
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.
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.
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Typical-developed:
People with disabilities:
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The measurement would be done in seat inclination angles of 5 degrees with 1 ml water intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 5 degrees with 5 ml water intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 5 degrees with 5 ml pudding intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 15 degrees with 1 ml water intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 15 degrees with 5 ml water intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 15 degrees with 5 ml pudding intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 30 degrees with 1 ml water intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 30 degrees with 5 ml water intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 30 degrees with 5 ml pudding intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 45 degrees with 1 ml water intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 45 degrees with 5 ml water intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 45 degrees with 5 ml pudding intake.
Behavioral: angle of inclination · Other: food type
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
the swallowing was tested with 3 food types
Electromyography
Two electrodes were attached to the submandibular muscle to register the electric potential generated by the muscles.
Time frame: 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.
Time frame: 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.
Time frame: 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital