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出境医 / 临床实验 / Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study

Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study

Study Description
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
Arms and Interventions
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
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

Locations
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United States, North Carolina
Methodist Universtiy
Fayetteville, North Carolina, United States, 28311
Sponsors and Collaborators
Methodist University, North Carolina
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE November 1, 2018
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		Activity Specific Balance Confidence Scale [ Time Frame: 2-6 months ]
Perceived self confidence with balance
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Dizziness handicap inventory [ Time Frame: 2-6 months ]
    Perceived handicap from dizziness
  • Functional Gait Assessment [ Time Frame: 2-6 months ]
    Gait and balance test
  • Motion Sensitivity Quotient [ Time Frame: 2-6 months ]
    Motion sickness indicator
  • Modified Clinical Test for Sensory Integration in Blance [ Time Frame: 2-6 months ]
    balance test for sensory system inputs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study
Official Title  ICMJE Vestibular Rehabilitation for Chronic Central Vestibular Deficits Due to Cerebellar Dysfunction
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Case study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vestibular Disorder
  • Fall
  • Coordination and Balance Disturbances
Intervention  ICMJE Other: Vestibular Rehabilitation
standard vestibular rehabilitation with gaze stability, balance training, habituation tailored to the subject
Study Arms  ICMJE Mobility
Self comparison of data from pre-post intervention.
Intervention: Other: Vestibular Rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2019) 		1
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 30, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Central vestibular deficits

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952936
Other Study ID Numbers  ICMJE 5/14/2020 CVD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stacia Britton, Methodist University, North Carolina
Study Sponsor  ICMJE Methodist University, North Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Methodist University, North Carolina
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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