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

Not Applicable

Conditions: M34.0
Progressive systemic sclerosis

Registration Number: DRKS00020776

Lead Sponsor: Campus Kerckhoff der Justus-Liebig-Universität Gießen, Abt. Osteologie und Physikalische Medizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 77

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

- 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Frequency of oropharyngeal dysfunction (at least 1 positive criteria) in patients with systemic sclerosis<br><br>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).<br><br>Patients will assess (subjective): oropharyngeal dysphagia (impairment of oropharyngeal swallowing), Reflux, Impairment of voice, impairment in speaking/articulation.<br><br>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 Outcome Measures

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