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Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03952936
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Stacia Britton, Methodist University, North Carolina

Study Description
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Brief Summary:
The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.

Condition or disease Intervention/treatment Phase
Vestibular Disorder Fall Coordination and Balance Disturbances Other: Vestibular Rehabilitation Not Applicable

Detailed Description:

The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.

Investigators will test the subject initially at 4 weeks, 8 weeks and 6 months post start date to assess for symptom improvement.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Case study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vestibular Rehabilitation for Chronic Central Vestibular Deficits Due to Cerebellar Dysfunction
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Mobility
Self comparison of data from pre-post intervention.
 Other: Vestibular Rehabilitation
standard vestibular rehabilitation with gaze stability, balance training, habituation tailored to the subject


Outcome Measures
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Primary Outcome Measures :
  1. Activity Specific Balance Confidence Scale [ Time Frame: 2-6 months ]
    Perceived self confidence with balance. 16 items are scored on a 0-100% scale. Items are totaled and then averaged. The higher the average score the higher the confidence with balance and the less likely risk there is for falling.


Secondary Outcome Measures :
  1. Dizziness handicap inventory [ Time Frame: 2-6 months ]
    Perceived handicap from dizziness. Items are scored on a 0, 2 or 4 point scale with adding up the total number of the 26 items. The lower the score, the less perceived amount of handicap is present.

  2. Functional Gait Assessment [ Time Frame: 2-6 months ]
    Gait and balance test. 10 item test rated on each item from 0-3. total score is calculated of 10 items. the higher the score the less likely risk for falling is present.

  3. Motion Sensitivity Quotient [ Time Frame: 2-6 months ]
    Motion sickness indicator. 16 items are scored based on symptom severity and duration. positive items are calculated together to receive a percentage. the lower the percentage the less motion sensitivity a person has.

  4. Modified Clinical Test for Sensory Integration in Balance [ Time Frame: 2-6 months ]
    balance test for sensory system inputs. 6 item test to check for sensory integration with balance. each of the 6 items is calculated for length of time and amount of sway. the less the sway, the lower the score and the better the balance.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Central vestibular deficits

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952936


Locations
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United States, North Carolina
Methodist Universtiy
Fayetteville, North Carolina, United States, 28311
Sponsors and Collaborators
Methodist University, North Carolina
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Stacia Britton, Assistant Professor of Physical Therapy, Methodist University, North Carolina
ClinicalTrials.gov Identifier: NCT03952936    
Other Study ID Numbers: 5/14/2020 CVD
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases