Trunk Inclination on Respiratory-swallowing Coordination

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

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.

Study Overview

• Status: Completed
• Conditions: Disabling Disease
• Intervention / Treatment: Behavioral: angle of inclination; Other: food type

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Typical-developed:

1. ages ranged from 20 to 60 years old,

People with disabilities:

1. ages ranged from 20 to 60 years old,
2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Hsin-Yi K Cheng, PhD, Chang Gung University, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: disability; sensors; respiration; swallowing; positioning; assistive device
• Other Study ID Numbers: 201600752A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No