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

NCT04720872 | Completed

• 1 other identifier: University of Jaén.
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vestibular Disorder

Keywords

Manual therapy; vestibular rehabilitation; unilateral peripheral vestibular hypofunction; Dizziness; balance confidence; postural control.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• ABC-16 (Activities-specific Balance Confidence scale-16 ítems)

  Baseline-4 weeks

• STABILOMETRIC PLATFORM

  Baseline-4 weeks

• Visual-Analogue-Scale (VAS)

  Baseline-4 weeks

• The number of crisis

  Baseline-4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

* 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

Control group

NO INTERVENTION

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.

Interventions

Manual therapy and vestibular rehabilitation treatment OTHER

The experimental group received manual therapy and vestibular rehabilitation treatment.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

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

Jaén, Spain

Location

MeSH Terms

Conditions

Dizziness

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: January 20, 2021
• Primary Completion: October 31, 2021
• Study Completion: January 31, 2022
• Last Updated: February 3, 2022

Record last verified: 2022-02

Locations

ES (1)