Manual Therapy With Directed Vestibular Rehabilitation in Patients With Unilateral Peripheral Vestibular Hypofunction.

Not Applicable

Completed

• Conditions: Peripheral Vestibular Disorder
• Interventions: Other: Manual therapy and vestibular rehabilitation treatment

• Registration Number: NCT04720872
• Lead Sponsor: University of Jaén

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-01-19
• Study Start: 2021-01-20
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Primary Completion: 2021-10-31
• Study Completion: 2022-01-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients aged ≥ 18 years with a clinical diagnosis of unilateral peripheral vestibular hypofunction confirmed by Video Head Impulse Test (< 0.8), referring balance impairments, postural instability, gait instability, vertigo, dizziness or motion sensitivity, able to understand and complete e instructions, programs, and protocols of this project, and providing a signed informed consent.

Exclusion Criteria

• Central nervous system, degenerative or cancer diseases, acute infection.
• Morphological/ functional alterations of the lower limbs, and/or morphological alteration of the cervical and/or suboccipital rachis.
• Conditions (i.e. neuromuscular disease or traumatism) that contraindicate the performance of the exercises and interventions of this study, as well as cognitive impairment that prevents the participants from understanding and completing the questionnaires and interventions.
• Positive results for the Klein test and the Rancurel test, or cerebrovascular alterations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Manual therapy and vestibular rehabilitation treatment	* 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).

Primary Outcome Measures

Name	Time	Method
Dizziness Handicap Inventory	Baseline-4 weeks	Evaluates the level of disability related to the impact of dizziness on daily function and quality of life.

Secondary Outcome Measures

Name	Time	Method
ABC-16 (Activities-specific Balance Confidence scale-16 ítems)	Baseline-4 weeks	Questionnaire that assesses balance confidence in performing activities of daily living.
STABILOMETRIC PLATFORM	Baseline-4 weeks	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.
Visual-Analogue-Scale (VAS)	Baseline-4 weeks	The intensity of the vertiginous crisis will be assessed by a visual-analogue-scale during the 4 weeks of the intervention period, respectively.
The number of crisis	Baseline-4 weeks	The frequency of the vertiginous crisis will be assessed by the number of crisis during the 4 weeks of the intervention period, respectively.

Trial Locations

Locations (1)

Complejo Hospitalario Ciudad de Jaén. Av. del Ejército Español, 10, 23007; University of Jaén. Campus Las Lagunillas s/n. 23071; 🇪🇸 Jaén, Spain