NCT02821663

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

June 24, 2016

Last Update Submit

April 12, 2017

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

  • MOS 36-Item Short Form Health Survey

    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 Outcomes (4)

  • Mouth open; in millimeter

    up to 4 weeks

  • 6-minutes walk test

    up to 4 weeks

  • Secretory immunoglobulin A; mg/l

    up to 4 weeks

  • Saliva cortisol; ng/ml

    up to 4 weeks

Study Arms (1)

Vocal intervention

EXPERIMENTAL

Vocal intervention

Behavioral: vocal intervention

Interventions

vocal interventionBEHAVIORAL

10 x 60 min. sessions of vocal intervention

Vocal intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Medical University of Vienna

Vienna, A-1090, Austria

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Michael Mickel, MD

    Deptartment of Physical Medicine and Rehabilitation, MUW

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Mickel, MD

CONTACT

michael.mickel@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 24, 2016

First Posted

July 1, 2016

Study Start

November 1, 2014

Primary Completion

October 1, 2017

Study Completion

February 1, 2018

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

AU(1)