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

NCT ID: NCT04720872

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2022-01-31

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.

Conditions

Peripheral Vestibular Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental group

• 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).

Group Type: EXPERIMENTAL

Manual therapy and vestibular rehabilitation treatment

Intervention Type: OTHER

The experimental group received manual therapy and vestibular rehabilitation treatment.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Manual therapy and vestibular rehabilitation treatment

The experimental group received manual therapy and vestibular rehabilitation treatment.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Agustín Aibar Almazán

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Jaén, , Spain

Countries

Spain

Other Identifiers

University of Jaén.

Identifier Type: -

Identifier Source: org_study_id