NCT01729039: DZO

Vestibular Rehabilitation and Dizziness

Completed NA Results posted Last updated 22 August 2018

What this trial tests

NA trial testing standard balance rehabilitation in Dizziness in 49 participants. Completed in 28 February 2017.

Timeline

1 November 2012

Primary endpoint
30 September 2016

28 February 2017

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	49
Start date	1 November 2012
Primary completion	30 September 2016
Estimated completion	28 February 2017
Sites	2 locations across United States

Drugs / interventions tested

• standard balance rehabilitation
• gaze stability
• Control

Conditions studied

• Dizziness — all drugs for Dizziness →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

50 and older, any sex, with Dizziness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Analog Scale - Head Movement Primary · 6 weeks

This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.

Group	Value	95% CI
Gaze Stability	1.56	± 2.55
Control	1.81	± 2.08

Visual Analog Scale - Disequilibrium Primary · 6 weeks

This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.

Group	Value	95% CI
Gaze Stability	1.66	± 2.29
Control	1.96	± 2.37

Dynamic Gait Index Secondary · 6 weeks

The dynamic gait index (DGI) assesses an individual's ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of \< 20 indicate high risk for falling.

Group	Value	95% CI
Gaze Stability	21.54	± 2.02
Control	21.21	± 2.78

Activities-specific Balance Confidence Scale Secondary · 6 weeks

As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure the subject's confidence with their balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.

Group	Value	95% CI
Gaze Stability	83.98	± 14.40
Control	83.37	± 6.30

10 Meter Walk Test Secondary · 6 weeks

This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.

Group	Value	95% CI
Gaze Stability	3.15	± 0.54
Control	3.28	± 0.69

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gaze Stability

Serious: 1/23 (4%)

Deaths: 1/23

Control

Serious: 0/26 (0%)

Deaths: 0/26

Serious adverse events (1 terms)

Reaction	System	Gaze Stability	Control
Fall resulting in fracture	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Gaze Stability	Control
Fall without injury	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Fall resulting in fracture.

Data from ClinicalTrials.gov NCT01729039 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether vestibular exercises provide added benefit to balance rehabilitation in older adults with dizziness and normal vestibular function.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.