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

Primary Purpose

Peripheral Vestibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy and vestibular rehabilitation treatment
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vestibular Disorder focused on measuring Manual therapy; vestibular rehabilitation; unilateral peripheral vestibular hypofunction; Dizziness; balance confidence; postural control.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Dizziness Handicap Inventory
Evaluates the level of disability related to the impact of dizziness on daily function and quality of life.

Secondary Outcome Measures

ABC-16 (Activities-specific Balance Confidence scale-16 ítems)
Questionnaire that assesses balance confidence in performing activities of daily living.
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.
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.
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.

Full Information

First Posted
January 19, 2021
Last Updated
February 1, 2022
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT04720872
Brief Title
Manual Therapy With Directed Vestibular Rehabilitation in Patients With Unilateral Peripheral Vestibular Hypofunction.
Official Title
Manual Therapy Combined With Physical Therapist-Directed Vestibular Rehabilitation in Patients With Unilateral Peripheral Vestibular Hypofunction: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vestibular Disorder
Keywords
Manual therapy; vestibular rehabilitation; unilateral peripheral vestibular hypofunction; Dizziness; balance confidence; postural control.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual therapy and vestibular rehabilitation treatment
Intervention Description
The experimental group received manual therapy and vestibular rehabilitation treatment.
Primary Outcome Measure Information:
Title
Dizziness Handicap Inventory
Description
Evaluates the level of disability related to the impact of dizziness on daily function and quality of life.
Time Frame
Baseline-4 weeks
Secondary Outcome Measure Information:
Title
ABC-16 (Activities-specific Balance Confidence scale-16 ítems)
Description
Questionnaire that assesses balance confidence in performing activities of daily living.
Time Frame
Baseline-4 weeks
Title
STABILOMETRIC PLATFORM
Description
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
Title
Visual-Analogue-Scale (VAS)
Description
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
Title
The number of crisis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Complejo Hospitalario Ciudad de Jaén. Av. del Ejército Español, 10, 23007; University of Jaén. Campus Las Lagunillas s/n. 23071
City
Jaén
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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