An interventional study of Manual therapy and vestibular rehabilitation treatment in Peripheral Vestibular Disorder, sponsored by University of Jaén. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-03.
Sponsored by University of Jaén · Not applicable, Interventional, and Treatment
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.
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.
172 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's enrollment of 80 is above the median of 44 across 130 interventional studies indexed under Vestibular Diseases.
Browse Vestibular Diseases studies →University of Jaén is the lead sponsor of 79 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
* Manual therapy: 4 sessions, 1 session per week (20 minutes approximately). * Physical therapist-directed vestibular rehabilitation: 4 weeks, 1 session per week with the physical therapist (30 minutes approximately), after manual therapy. * Home based vestibular rehabilitation: 4 weeks (2 sessions per day).
Other: Manual therapy and vestibular rehabilitation treatment
Home based vestibular rehabilitation: 4 weeks (2 sessions per day). The participants attended the center once a week to check correct execution of the exercises.
The experimental group received manual therapy and vestibular rehabilitation treatment.
Dizziness Handicap Inventory
Evaluates the level of disability related to the impact of dizziness on daily function and quality of life.
Time frame: Baseline-4 weeks
ABC-16 (Activities-specific Balance Confidence scale-16 ítems)
Questionnaire that assesses balance confidence in performing activities of daily living.
Time frame: Baseline-4 weeks
STABILOMETRIC PLATFORM
Instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions.
Time frame: Baseline-4 weeks
Visual-Analogue-Scale (VAS)
The intensity of the vertiginous crisis will be assessed by a visual-analogue-scale during the 4 weeks of the intervention period, respectively.
Time frame: Baseline-4 weeks
The number of crisis
The frequency of the vertiginous crisis will be assessed by the number of crisis during the 4 weeks of the intervention period, respectively.
Time frame: Baseline-4 weeks
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University of Jaén