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

Peripheral Vestibular Disorder Clinical Trial

Official title:

Manual Therapy Combined With Physical Therapist-Directed Vestibular Rehabilitation in Patients With Unilateral Peripheral Vestibular Hypofunction: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720872
• Other study ID #: University of Jaén.
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Vestibular Disorder
• Vestibular Diseases

Intervention

Other:
• Manual therapy and vestibular rehabilitation treatment
The experimental group received manual therapy and vestibular rehabilitation treatment.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dizziness Handicap Inventory	Evaluates the level of disability related to the impact of dizziness on daily function and quality of life.	Baseline-4 weeks
Secondary	ABC-16 (Activities-specific Balance Confidence scale-16 ítems)	Questionnaire that assesses balance confidence in performing activities of daily living.	Baseline-4 weeks
Secondary	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.	Baseline-4 weeks
Secondary	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.	Baseline-4 weeks
Secondary	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.	Baseline-4 weeks