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| Tracking Information | |||||
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| First Received Date ICMJE | October 18, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | August 1995 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004366 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pilot Study of Vestibular Rehabilitation Training for Panic Disorder With Vestibular Dysfunction | ||||
| Official Title ICMJE | |||||
| Brief Summary | OBJECTIVES: I. Evaluate whether vestibular rehabilitation training is of value in reducing anxiety symptoms in patients with panic disorder with or without agoraphobia who have vestibular dysfunction as identified by clinical vestibular tests. |
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| Detailed Description | PROTOCOL OUTLINE: During the first 4 weeks of study, patients meet with a clinical nurse specialist once a week for approximately 1 hour. During this time, the nature of the anxiety disorder is explained and exposure to previously feared situations is encouraged. Only patients who remain symptomatic at a stable level following self-exposure will proceed with rehabilitation training. Patients meet with a physical therapist once a week for 4 weeks to further evaluate the extent of problems associated with balance. Then, patients undergo weekly 1 hour exercises for 8 weeks with the physical therapist, focusing on sensation, head and eye coordination, movement with eyes opened and closed, and gait. Concurrently, patients meet with the clinical nurse specialist every 4 weeks during and after physical therapy to evaluate the effects of vestibular treatment on anxiety symptoms. Training is continued if patient is symptomatic; otherwise, patient is discharged from study. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Educational/Counseling/Training, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: Physical therapy | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | May 2000 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004366 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 199/11944, UPITTS-11760S-950866, 11760S-950866 | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | University of Pittsburgh | ||||
| Investigators ICMJE |
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| Information Provided By | Office of Rare Diseases (ORD) | ||||
| Verification Date | June 2000 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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