NCT03952936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

May 14, 2019

Last Update Submit

October 18, 2023

Conditions

Vestibular DisorderFallCoordination and Balance Disturbances

Outcome Measures

Primary Outcomes (1)

  • 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.

    2-6 months

Secondary Outcomes (4)

  • Dizziness handicap inventory

    2-6 months

  • Functional Gait Assessment

    2-6 months

  • Motion Sensitivity Quotient

    2-6 months

  • Modified Clinical Test for Sensory Integration in Balance

    2-6 months

Study Arms (1)

Mobility

OTHER

Self comparison of data from pre-post intervention.

Other: Vestibular Rehabilitation

Interventions

Vestibular RehabilitationOTHER

standard vestibular rehabilitation with gaze stability, balance training, habituation tailored to the subject

Mobility

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Central vestibular deficits

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Universtiy

Fayetteville, North Carolina, 28311, United States

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Case study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 16, 2019

Study Start

November 1, 2018

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)