Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The current cervical range of motion (CROM) and tongue movement measurement methods are not reliable between observers, which is not practical in real-world usage. This research is to develop the cervical range of motion measurement, and tongue movement estimation software, to compare between the developed software and the current measurement techniques, and to test in clinical aspects for reliability and validity assessment. The investigators investigate the developed software in healthy people in phase 1. In phases 2 and 3, the investigators compare the software to the standard measurement methods in dysphagic patients who have head and neck cancer for reliability and validity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation assessment software | Experimental | This arm applies the developed rehabilitation assessment software by using two web cameras placed in the front and the side of the subject. The subject sits between two cameras. The observer asks the subject to move the head in each direction, to open the mouth, and to move the tongue. The software will measure CROM, mouth opening, and tongue movement. |
|
| video-fluoroscopic swallowing and FOIS. | Experimental | This arm applies video-fluoroscopic swallowing (VFSS) and functional oral intake scale (FOIS) to measure the direct, dynamic view of oral, pharyngeal, and upper esophageal function during swallowing with food and liquid mixed with barium, and the functional intake of dysphagic patients, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation assessment software | Device | In phase 2, this software will be tested in occupational therapists, and head and neck cancer patients results for reliability and validity. In phase 3, the experiment in the oropharyngeal dysphagia specialists results in content validity, the comparison between the developed software, and VFSS and FOIS results in criterion-related validity, and the experiment in head and neck cancer patients results in reliability. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method. | The same investigator will repeat cervical range of motion measurement by using the developed rehabilitation software and the standard cervical range of motion (CROM) measurement method from the goniometer. | One hour |
| Inter-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method. | The cervical range of motion (CROM) measurement by using the developed rehabilitation software and the standard CROM measurement method from the goniometer will be repeated by different observers. | One hour |
| Concurrent measurement validity between the developed rehabilitation assessment software and the standard CROM measurement method. | The correlation of the concurrent cervical range of motion (CROM) measurement outcome at approximately the same time between the developed rehabilitation assessment software and the standard CROM measurement method from the goniometer. | One hour |
| Criterion-related validity between the developed rehabilitation assessment software, and VFSS and FOIS. | The criterion-related validity of the rehabilitation assessment software will be assessed by the correlation between the cervical range of motion measurement by the developed rehabilitation assessment software and the functional swallowing assessment by videofluoroscopic Swallowing Study (VFSS), and functional oral intake scale (FOIS). | One month |
Not provided
Not provided
Inclusion Criteria in Phase 2
Occupational therapist
Head and neck cancer patients
Exclusion Criteria in Phase 2
Occupational therapist
Head and neck cancer patients
Inclusion Criteria in Phase 3
Dysphagic Specialist
Observers
Head and neck cancer patients The criteria are the same as the inclusion criteria of head and neck cancer patients in phase 2.
Exclusion Criteria in Phase 3
Dysphagic Specialist
Observers
Head and neck cancer patients The criteria are the same as the exclusion criteria of head and neck cancer patients in phase 2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Panrasee Ritthipravat | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine, Ramathibodhi Hospital | Phaya Thai | Bangkok | 10400 | Thailand |
The data requires to be confidential. It is prohibited to share the participant-level data.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D005355 | Fibrosis |
| D009369 | Neoplasms |
| D011832 | Radiation Injuries |
| D003966 | Camurati-Engelmann Syndrome |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| VFSS and FOIS | Device | In phase 3, this study applies VFSS and FOIS for the head and neck cancer patients for comparison with the developed rehabilitation assessment software for criterion-related validity. |
|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |