NCT04367194

Brief Summary

Dizziness (BPPV) causes severe deterioration in quality of life, incoordination, and instability. In the study, we selected a minimum of 100 patients with BPPV who were examined after specialist care. After the acute phase, a physical survey is performed where movement and coordination are examined. After the results, the patients undergo a rehabilitation training. The workout is submaximal and high intensity that is done for 3 weeks. Hypothesis: As a result of training, it is possible that the remaining feeling of dizziness and insecurity, impaired coordination will decrease or disappear.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2020

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

April 23, 2020

Last Update Submit

January 11, 2021

Conditions

Keywords

vertigobalanceinstabilityrehabilitation

Outcome Measures

Primary Outcomes (3)

  • EQ5D-5L

    Quality of life testing is taken with a test. The therapist scores the answers to the questions asked on a scale. The end result determines the quality of life.

    5 weeks

  • Beam Walking test

    The patient walks on slats of varying width. During the examination, the therapist says the tasks (Eg: counting backwards). The study detects the determination of dynamic equilibrium.

    5 weeks

  • Posturography

    Noninvasive intervention where static equilibrium is examined. The program determines the quality and frequency of the displacements.

    5 weeks

Study Arms (3)

BPPV intervention

EXPERIMENTAL

After examination of the patients, the patients undergo neurorehabilitation. We use virtual reality therapy. Patients perform a submaximal load that is monitored by a polar clock. We develop endurance, coordination, sensory integration, visual and acoustic input, vestibular training, proprioception training.

Behavioral: Neurorehabilitation

BPPV Epley

EXPERIMENTAL

Only Epley training.

Behavioral: Neurorehabilitation

BPPV Optocinetic

EXPERIMENTAL

Only Optocinetic training.

Behavioral: Neurorehabilitation

Interventions

After examination of the patients, the patients undergo neurorehabilitation. We use virtual reality therapy. Patients perform a submaximal load that is monitored by a polar clock. We develop endurance, coordination, sensory integration, visual and acoustic input, vestibular training, proprioception training.

Also known as: BPPV group
BPPV EpleyBPPV OptocineticBPPV intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • For a patient with BPPV
  • With a lack of coordination
  • Dizziness
  • Ear nose laryngeal examination
  • Neurological examination

You may not qualify if:

  • other neurological diseases
  • cardiological diseases
  • underwent surgery
  • severe joint pain
  • alcoholism
  • dementia
  • drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, Somogy County, 7400, Hungary

Location

Related Links

MeSH Terms

Conditions

VertigoMotor Skills Disorders

Interventions

Neurological Rehabilitation

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 29, 2020

Study Start

April 23, 2018

Primary Completion

June 23, 2020

Study Completion

June 23, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations