NCT00275392

Brief Summary

The purpose of this study is to develop effective exercise intervention to reduce dizziness and fall risk in older adults with non-specific dizziness. We hypothesize that the use of vestibular exercises can reduce dizziness and improve gaze and postural stability in older persons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 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

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

October 17, 2014

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

3.3 years

First QC Date

January 10, 2006

Results QC Date

September 17, 2014

Last Update Submit

December 5, 2014

Conditions

Keywords

DizzinessGeriatricsRehabilitationVestibular rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Dynamic Gait Index

    Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of \< 20 indicates risk for falling.

    6 weeks

Secondary Outcomes (1)

  • Dynamic Visual Acuity

    6 weeks

Study Arms (2)

Vestibular Rehabilitation

EXPERIMENTAL

vestibular exercises plus standard balance and gait exercises

Behavioral: Vestibular rehabilitation

Placebo

PLACEBO COMPARATOR

placebo exercises plus standard balance and gait exercises

Behavioral: Placebo

Interventions

vestibular adaptation and substitution exercises

Vestibular Rehabilitation
PlaceboBEHAVIORAL

placebo vestibular exercises

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be at least 60 years of age, seeking medical care due to dizziness and have normal vestibular function based on results of the clinical examination, rotary chair and/or caloric tests.

You may not qualify if:

  • Abnormal vestibular function based on results of clinical examination, rotary chair and/or caloric tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

Related Publications (1)

  • Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Courtney D. Hall, PhD
Organization
James H. Quillen VAMC

Study Officials

  • Courtney D. Hall, PhD PT

    Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

April 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

December 9, 2014

Results First Posted

October 17, 2014

Record last verified: 2014-12

Locations