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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821663
|Contact: Michael Mickel, MDemail@example.com|
|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|