search
Back to results

Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study

Primary Purpose

Vestibular Disorder, Fall, Coordination and Balance Disturbances

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular Rehabilitation
Sponsored by
Methodist University, North Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Central vestibular deficits

Exclusion Criteria:

  • None

Sites / Locations

  • Methodist Universtiy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Mobility

Arm Description

Self comparison of data from pre-post intervention.

Outcomes

Primary Outcome Measures

Activity Specific Balance Confidence Scale
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

Dizziness handicap inventory
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
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
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
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.

Full Information

First Posted
May 14, 2019
Last Updated
October 18, 2023
Sponsor
Methodist University, North Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT03952936
Brief Title
Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study
Official Title
Vestibular Rehabilitation for Chronic Central Vestibular Deficits Due to Cerebellar Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Methodist University, North Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder, Fall, Coordination and Balance Disturbances

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case study
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobility
Arm Type
Other
Arm Description
Self comparison of data from pre-post intervention.
Intervention Type
Other
Intervention Name(s)
Vestibular Rehabilitation
Intervention Description
standard vestibular rehabilitation with gaze stability, balance training, habituation tailored to the subject
Primary Outcome Measure Information:
Title
Activity Specific Balance Confidence Scale
Description
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.
Time Frame
2-6 months
Secondary Outcome Measure Information:
Title
Dizziness handicap inventory
Description
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.
Time Frame
2-6 months
Title
Functional Gait Assessment
Description
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.
Time Frame
2-6 months
Title
Motion Sensitivity Quotient
Description
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.
Time Frame
2-6 months
Title
Modified Clinical Test for Sensory Integration in Balance
Description
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.
Time Frame
2-6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Central vestibular deficits Exclusion Criteria: None
Facility Information:
Facility Name
Methodist Universtiy
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28311
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study

We'll reach out to this number within 24 hrs