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NCT01307475 · ClinicalTrials.gov registry record

Study of Quality of Life in Freeman-Sheldon Syndrome and Related Conditions

A clinical trial, sponsored by Freeman-Sheldon Research Group.

Terminated
Registry status
6
Enrollment target

NCT01307475 is a clinical trial that was terminated before completion, run by Freeman-Sheldon Research Group. The registered enrollment target is 6 participants.

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The verdict

NCT01307475 was terminated before completion, sponsored by Freeman-Sheldon Research Group.

TERMINATED
Registry status
6 participants
Enrollment target

Study Summary

Freeman-Sheldon syndrome (FSS) is a rare human neuromusculoskeletal disorder present before birth, involving primarily limb and craniofacial deformities. The hypotheses in the present study of FSS and related conditions are: (1) FSS and related conditions are associated with higher rates of posttraumatic stress symptoms (PTSS), depression, and reduced quality of life than is observed in the general population; (2) persons close to an individual with FSS or related condition suffer similarly; and (3) current measures, which are single-disease specific (i.e., PTSS, depression, craniofacial deformities, or limb deformities), do not capture the unique picture of FSS and related conditions, which involve both limb and craniofacial deformities in an intellectually capable individual. There have been no studies looking at quality of life associated with FSS. Some authors have looked at quality of life in persons with facial differences; other authors have looked at bone and joint problems. Many other authors have looked at PTSS and depression caused by health problems and bad medical experiences. No authors have looked at these problems when they happen together, as they do in FSS. Because of the above, there may be differences in patients that have FSS versus patients in previous quality of life studies. The study will also develop and validate an outcomes-based quality of life survey for FSS and related conditions.

Interventions

  • OTHER PTSD Checklist-Specific
  • OTHER Modified Flanagan Quality of Life Scale
  • OTHER Center for Epidemiologic Studies Depression Scale
  • OTHER Functional Enquiry Form
  • OTHER Strength, Joint ROM, Girth and Length Measurements

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2011-02
Est. Completion 2017-04-01

Sponsor

Freeman-Sheldon Research Group

3 total trials

What the Registry Record Tells You About NCT01307475

The ClinicalTrials.gov registry entry for NCT01307475 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Freeman-Sheldon Research Group, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which PTSD Checklist-Specific is the first listed.

NCT01307475 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01307475 about?

NCT01307475 is a clinical study titled "Study of Quality of Life in Freeman-Sheldon Syndrome and Related Conditions". Freeman-Sheldon syndrome (FSS) is a rare human neuromusculoskeletal disorder present before birth, involving primarily limb and craniofacial deformities. The hypotheses in the present study of FSS and related conditions are: (1) FSS and related conditions are associated with higher rates of posttra...

What is the current status of trial NCT01307475?

This trial is currently terminated. The enrollment target is 6 participants. The study started on 2011-02. Estimated completion is 2017-04-01.

What interventions are being tested in trial NCT01307475?

The interventions under investigation include: PTSD Checklist-Specific (OTHER), Modified Flanagan Quality of Life Scale (OTHER), Center for Epidemiologic Studies Depression Scale (OTHER), Functional Enquiry Form (OTHER), Strength, Joint ROM, Girth and Length Measurements (OTHER).

Who is sponsoring clinical trial NCT01307475?

This trial is sponsored by Freeman-Sheldon Research Group, which has 3 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.