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The Swallowing Exercise Aid in Total Laryngectomy: Feasibility, Adherence and a Multidimensional Assessment of Functional-, Physical-, and Patient-reported outcomes

The Swallowing Exercise Aid in Total Laryngectomy: Feasibility, Adherence and a Multidimensional Assessment of Functional-, Physical-, and Patient-reported outcomes - SEATTLE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50048
Enrollment
20
Registered
2021-10-27
Start date
2022-04-21
Completion date
Unknown
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hoofdhalskankerpatienten die een totale laryngectomie hebben ondergaan dysphagia Larynx extirpation

Interventions

All participants have to train three different strengthening exercises with the SEA three times a day, including the Chin Tuck against resistance (CTAR+), Jaw Opening against resistance (JOAR+), and

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • >= 18 years or older • Undergone a TLE • At least six months post TLE • At least six months postoperative (chemo-) radiotherapy (if applicable) • Using Tracheoesophageal speech • Oral intake of a modified diet (FOIS 2 - 6) or who experience swallowing problems • Signed informed consent

Exclusion criteria

Exclusion criteria: • Unable to understand the patient information • Unable to understand the informed consent • Unable to comprehend and use the SEA • Unable or unwilling to provide informed consent • Neuro-degenerative diseases, for instance, dementia, Parkinson, Korsakov

Design outcomes

Primary

MeasureTime frame
This study has a multidimensional assessment approach, including feasibility and adherence, physical outcomes, functional outcomes, and patient-reported outcomes. In this study, measures of interest are muscle strength, manofluorography, manometry, voice recordings, dynamic range of voice, maximum fonation time, questionnaires, and information from the electronic medical files.

Secondary

MeasureTime frame
Secondary: (Multidimensional Evaluation) Physical outcomes: - Strength measurement (IOPI, dynamometer) - Manofluorography - Pressure measurement during breathing and vocalization (manometry) Functional Outcomes: - Voice recordings - Mouth opening Subjective outcomes: - Questionnaires on Quality of life, swallowing problems, voice problems, participation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)