Vocal Intervention in Systemic Sclerosis
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|ClinicalTrials.gov Identifier: NCT02821663|
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis||Behavioral: vocal intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rehabilitation in Patients Suffering From Systemic Sclerosis by Vocal Intervention: A Pilot Study|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||February 2018|
Experimental: Vocal intervention
Behavioral: vocal intervention
10 x 60 min. sessions of vocal intervention
- MOS 36-Item Short Form Health Survey [ Time Frame: up to 4 weeks ]The SF-36 - a patient-reported survey of patient health - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
- Mouth open; in millimeter [ Time Frame: up to 4 weeks ]incisor to incisor; corner of mouth to corner of mouth; measurement by tape
- 6-minutes walk test [ Time Frame: up to 4 weeks ]The 6-minute walk test assess changes in functional exercise capacity with the primary outcome reported being the distance walked during the test.
- Secretory immunoglobulin A; mg/l [ Time Frame: up to 4 weeks ]Immunoglobulin A is an antibody that plays a role in immune function in the mucous membranes. Indicates changes in immune status. Collected by a swab placed in the mouth.
- Saliva cortisol; ng/ml [ Time Frame: up to 4 weeks ]Cortisol is a steroid hormone indicating changes in stress status. Collected by a swab placed in the mouth.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821663
|Contact: Michael Mickel, MDfirstname.lastname@example.org|
|Department of Physical Medicine and Rehabilitation, Medical University of Vienna||Recruiting|
|Vienna, Austria, A-1090|
|Principal Investigator:||Michael Mickel, MD||Deptartment of Physical Medicine and Rehabilitation, MUW|