Vocal Intervention in Systemic Sclerosis

April 12, 2017 updated by: Michael Mickel, Medical University of Vienna

Rehabilitation in Patients Suffering From Systemic Sclerosis by Vocal Intervention: A Pilot Study

Systemic sclerosis is a systemic connective tissue disease with physical and mental disturbances. Based on a pilot study the feasibility and effectiveness of a novel, self-developed concept of vocal intervention in Systemic Sclerosis under vocal pedagogical guidance and music therapy is assessed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This concept aims at functional improvement of respiration and mouth-opening, enhancement of Quality of Life, and reduction of stress carried out by a music therapist and singer with pedagogical formation.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Recruiting
        • Department of Physical Medicine and Rehabilitation, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • positive criteria for Systemic Sclerosis according to the American College of Rheumatology/European League Against Rheumatism

Exclusion Criteria:

  • affection of the vocal apparatus
  • dyspnea at rest
  • oxygen prescription

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vocal intervention
Behavioral: vocal intervention
10 x 60 min. sessions of vocal intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mouth open; in millimeter
Time Frame: up to 4 weeks
incisor to incisor; corner of mouth to corner of mouth; measurement by tape
up to 4 weeks
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.
up to 4 weeks
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.
up to 4 weeks
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.
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Michael Mickel, MD, Deptartment of Physical Medicine and Rehabilitation, MUW

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSc-1-MM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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