Oropharyngeal dysfunction in patients with systemic sclerosis: frequency and therapeutic effects of speech therapy

Oropharyngeal dysfunction in patients with systemic sclerosis: frequency and therapeutic effects of speech therapy - LogoSS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020776

Enrollment

Registered

2020-03-16

Start date

2021-01-05

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

M34.0

Interventions

Group 1: Patiens with systemic sclerosis At start oropharyngeal dysfunction will be assessed subjectively by the patient as well as objectively by a speech therapist. Oropharyngeal dysfunction compr

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 18 - 99 years of age - systemic sclerosis (both limited and diffuse cutaneous systemic sclerosis) Meeting the ACR/EULAR classification criteria 2013 - Written informed consent obtained from the subject or his/her legally acceptable representative - Understanding of study procedures and willingness to abide by all procedures during the course of the study.

Exclusion criteria

Exclusion criteria: - cognitive impairment - stroke (in the last 6 months) - aphasia - dementia, epilepsy or any other neurologic condition in which speech therapy cannot be administered - Myositis - dysphagia not due to systemic sclerosis - Ulcera / injury of the mouth or oropharynx - ventilation

Design outcomes

Primary

Measure	Time frame
1) Frequency of oropharyngeal dysfunction (at least 1 positive criteria) in patients with systemic sclerosis Oropharyngeal dysfunction comprises: oropharyngeal dysphagia (impairment of oropharyngeal swallowing), Reflux, impairment of voice, impairment in speaking/articulation, impairment in breathing (oropharyngeal breathing), impairment of oropharyngeal muscle function (tongue, palate, mimic muscles). Patients will assess (subjective): oropharyngeal dysphagia (impairment of oropharyngeal swallowing), Reflux, Impairment of voice, impairment in speaking/articulation. A speech therapist will assess (objective): oropharyngeal dysphagia (impairment of oropharyngeal swallowing), impairment of voice, impairment in speaking/articulation, impairment in breathing (oropharyngeal breathing), impairment of oropharyngeal muscle function (tongue, palate, mimic muscles).	—

Measure

Time frame

1) Frequency of oropharyngeal dysfunction (at least 1 positive criteria) in patients with systemic sclerosis Oropharyngeal dysfunction comprises: oropharyngeal dysphagia (impairment of oropharyngeal swallowing), Reflux, impairment of voice, impairment in speaking/articulation, impairment in breathing (oropharyngeal breathing), impairment of oropharyngeal muscle function (tongue, palate, mimic muscles). Patients will assess (subjective): oropharyngeal dysphagia (impairment of oropharyngeal swallowing), Reflux, Impairment of voice, impairment in speaking/articulation. A speech therapist will assess (objective): oropharyngeal dysphagia (impairment of oropharyngeal swallowing), impairment of voice, impairment in speaking/articulation, impairment in breathing (oropharyngeal breathing), impairment of oropharyngeal muscle function (tongue, palate, mimic muscles).

—

Secondary

Measure	Time frame
1. subjective improvement of oropharyngeal dysfunction in up to 7 days after initial speech therapy (2 appointments: Evaluation and therapy) assessed on a visual analogue scale (VAS) from 0 to 100 mm 2. subjective improvement of oropharyngeal dysfunction after 3 months of logopedic treatment assessed on a visual analogue scale (VAS) from 0 to 100 mm 3. objective improvement (logopedic reevaluation) of oropharyngeal dysfunction after 3 months of logopedic treatment (no improvement - little improvement - good improvement) 4. change in logopedic evaluation after 3 months of therapy using the Hoffmann-SSc-Scale 5. Change in bodyweight 6. Change in SHAQ, FFbH and HAQ 7. Change in daily doses and frequency of procinetic pharmacotherapy 8. Change in Hb, MCV, MCH and transferrinsaturation	—

Measure

Time frame

1. subjective improvement of oropharyngeal dysfunction in up to 7 days after initial speech therapy (2 appointments: Evaluation and therapy) assessed on a visual analogue scale (VAS) from 0 to 100 mm 2. subjective improvement of oropharyngeal dysfunction after 3 months of logopedic treatment assessed on a visual analogue scale (VAS) from 0 to 100 mm 3. objective improvement (logopedic reevaluation) of oropharyngeal dysfunction after 3 months of logopedic treatment (no improvement - little improvement - good improvement) 4. change in logopedic evaluation after 3 months of therapy using the Hoffmann-SSc-Scale 5. Change in bodyweight 6. Change in SHAQ, FFbH and HAQ 7. Change in daily doses and frequency of procinetic pharmacotherapy 8. Change in Hb, MCV, MCH and transferrinsaturation

—

Countries

Germany

Contacts

Public ContactPhilipp Klemm

Campus Kerckhoff der Justus-Liebig-Universität Gießen, Abt. Rheumatologie, Immunologie, Osteologie und Physikalische Medizin

p.klemm@kerckhoff-klinik.de06032-996-2101

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026