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Trunk Inclination on Respiratory-swallowing Coordination

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Disabling Disease

Treatments

Other: food type
Behavioral: angle of inclination

Study type

Interventional

Funder types

Other

Identifiers

NCT05221801
201600752A3

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

30 participants in 12 patient groups

angle 5 + 1ml water
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 5 degrees with 1 ml water intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 5 + 5 ml water
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 5 degrees with 5 ml water intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 5 + 5 ml pudding
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 5 degrees with 5 ml pudding intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 15 + 1ml water
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 15 degrees with 1 ml water intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 15 + 5 ml water
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 15 degrees with 5 ml water intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 15 + 5 ml pudding
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 15 degrees with 5 ml pudding intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 30 + 1ml water
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 30 degrees with 1 ml water intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 30 + 5 ml water
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 30 degrees with 5 ml water intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 30 + 5 ml pudding
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 30 degrees with 5 ml pudding intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 45 + 1ml water
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 45 degrees with 1 ml water intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 45 + 5 ml water
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 45 degrees with 5 ml water intake.
Treatment:
Behavioral: angle of inclination
Other: food type
angle 45 + 5 ml pudding
Active Comparator group
Description:
The measurement would be done in seat inclination angles of 45 degrees with 5 ml pudding intake.
Treatment:
Behavioral: angle of inclination
Other: food type

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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