Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04720872 |
Other study ID # |
University of Jaén. |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 20, 2021 |
Est. completion date |
January 31, 2022 |
Study information
Verified date |
February 2022 |
Source |
University of Jaén |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Randomized clinical trial with a control group that aims to evaluate the effects of a manual
therapy protocol, together with a physical therapist-directed vestibular rehabilitation
program, in patients with unilateral peripheral vestibular hypofunction. The intervention
period will last approximately 4 weeks. Outcome measures will be collected at baseline, just
after the intervention, as well as 1 and 6 months after the intervention.
Description:
Peripheral vestibular disorders are common in otorhinolaryngology practice. These patients
often complain of vertigo and dizziness, as well as balance problems, causing an important
impact on health-related quality of life. The objective of this study was to investigate the
effects of manual therapy combined with physical therapist-directed vestibular rehabilitation
in patients with unilateral peripheral vestibular hypofunction. The design of this study is a
randomized controlled trial with two groups (experimental and control groups). The impact of
dizziness on daily function and quality of life (Dizziness Handicap Inventory), the fear of
falling and the balance confidence (Activities-specific Balance Confidence scale-16 items),
postural control (stabilometric platform) as well as the intensity (visual analogue scale)
and number of the vertiginous crisis will be determined. The intervention period will last
four weeks. Participants of the experimental group will receive 4 sessions of manual therapy
together with physical therapist-directed vestibular rehabilitation, while participants of
the control group will receive home-based vestibular rehabilitation. Outcome measurements
will take place at baseline, immediately after the intervention, one month and six months
after the intervention. Within-group and between-group data will be analyzed and interpreted.