Vestibular DiseasesNCT00004366
Pilot Study of Vestibular Rehabilitation Training for Panic Disorder With Vestibular Dysfunction
A study testing Physical therapy in people with Vestibular Diseases and Agoraphobia, run by National Center for Research Resources (NCRR).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Vestibular Diseases, Agoraphobia, Panic Disorder
- What is being tested?
- Physical therapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 1995to May 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Diagnosed panic disorder with or without agoraphobia
- Vestibular dysfunction, as defined by abnormalities in the caloric and/or rotational tests
- Continued symptomatology after general instructions of the importance of exposure to feared situations
- Absence of acute symptoms of anxiety or depression assessed to need immediate clinical care
About this study
OBJECTIVES:
- 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.
Read the 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.
- Conditions
- Vestibular Diseases, Agoraphobia, Panic Disorder
- Being tested
- Physical therapy
- Keywords
- agoraphobia, anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, panic disorder, rare disease, vestibular diseases
- Medical subject headings
- Vestibular Diseases, Agoraphobia, Panic Disorder, Anxiety Disorders, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startAug 1995
- Study completionMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Pittsburgh
- Investigators
- Rolf G. Jacob, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004366
- Sponsor's protocol ID
- 199/11944
- Other IDs
- UPITTS-11760S-950866, 11760S-950866
- Status last verified
- Jun 2000
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Vestibular Rehabilitation Training for Panic Disorder With Vestibular Dysfunction
- ClinicalTrials.gov ID
- NCT00004366
- Acronym / sponsor ID
- 199/11944
- Conditions
- Vestibular Diseases, Agoraphobia, Panic Disorder
- Keywords
- agoraphobia, anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, panic disorder, rare disease, vestibular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- University of Pittsburgh
- Study start
- Aug 1995
- Study completion
- May 2000
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- 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.
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.
Study design
- Primary purpose
- Early clinical test
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf G. Jacob study chair
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy in people with Vestibular Diseases and Agoraphobia, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.