Trial Outcomes & Findings for Vestibular Rehabilitation and Dizziness in Geriatric Patients (NCT NCT00275392)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

6 weeks

Results posted on

2014-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	Vestibular Rehabilitation vestibular exercises plus standard balance and gait exercises Vestibular rehabilitation: vestibular adaptation and substitution exercises	Placebo placebo exercises plus standard balance and gait exercises Placebo Vestibular rehabilitation: placebo vestibular exercises
Overall Study STARTED	20	19
Overall Study COMPLETED	20	17
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vestibular Rehabilitation and Dizziness in Geriatric Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vestibular Rehabilitation n=20 Participants vestibular exercises plus standard balance and gait exercises Vestibular rehabilitation: vestibular adaptation and substitution exercises	Placebo n=17 Participants placebo exercises plus standard balance and gait exercises Placebo Vestibular rehabilitation: placebo vestibular exercises	Total n=37 Participants Total of all reporting groups
Age, Continuous	73.6 years STANDARD_DEVIATION 6.5 • n=5 Participants	74.5 years STANDARD_DEVIATION 8.5 • n=7 Participants	73.8 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Dynamic Gait Index	14.2 units on a scale STANDARD_DEVIATION 3.1 • n=5 Participants	16.1 units on a scale STANDARD_DEVIATION 2.6 • n=7 Participants	15.1 units on a scale STANDARD_DEVIATION 3.0 • n=5 Participants
Dynamic Visual Acuity	0.20 LogMAR STANDARD_DEVIATION 0.08 • n=5 Participants	0.14 LogMAR STANDARD_DEVIATION 0.07 • n=7 Participants	0.16 LogMAR STANDARD_DEVIATION 0.08 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Per-protocol analyses (i.e., only subjects who completed the intervention were included).

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.

Outcome measures

Outcome measures
Measure	Vestibular Rehabilitation n=20 Participants vestibular exercises plus standard balance and gait exercises Vestibular rehabilitation: vestibular adaptation and substitution exercises	Placebo n=17 Participants placebo exercises plus standard balance and gait exercises Placebo Vestibular rehabilitation: placebo vestibular exercises
Dynamic Gait Index Discharge (6 weeks)	18.9 units on a scale Standard Deviation 1.8	18.9 units on a scale Standard Deviation 3.0
Dynamic Gait Index Baseline	14.2 units on a scale Standard Deviation 3.1	16.1 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 6 weeks

Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity.

Outcome measures

Outcome measures
Measure	Vestibular Rehabilitation n=20 Participants vestibular exercises plus standard balance and gait exercises Vestibular rehabilitation: vestibular adaptation and substitution exercises	Placebo n=17 Participants placebo exercises plus standard balance and gait exercises Placebo Vestibular rehabilitation: placebo vestibular exercises
Dynamic Visual Acuity Discharge (6 weeks)	0.14 LogMAR Standard Deviation 0.07	0.19 LogMAR Standard Deviation 0.08
Dynamic Visual Acuity Baseline	0.20 LogMAR Standard Deviation 0.08	0.21 LogMAR Standard Deviation 0.10

Adverse Events

Vestibular Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Courtney D. Hall, PhD

James H. Quillen VAMC

Phone: 423-926-1171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place