<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04458376</url>
  </required_header>
  <id_info>
    <org_study_id>137107</org_study_id>
    <nct_id>NCT04458376</nct_id>
  </id_info>
  <brief_title>Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness</brief_title>
  <official_title>Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness; a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Møre og Romsdal HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helse Møre og Romsdal HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic dizziness,or persistent positional perceptual dizziness (PPPS) is a common condition&#xD;
      that results in impaired quality of life and work ability of those affected. Vestibular&#xD;
      Rehabilitation (VR) is an evidence-based and recommended treatment for chronic dizziness. The&#xD;
      treatment involves training in specific exercises that challenge the balance system and&#xD;
      eventually improve dizziness. The main challenge with this treatment is that it is usually&#xD;
      best provided with individual follow-up of therapists trained in the method. Limited&#xD;
      resources and the lack of dissemination of this knowledge mean that only a minority of&#xD;
      patients receive adequate treatment. An internet-based self-help program in vestibular&#xD;
      rehabilitation has been developed in Norwegian with demonstration and instructions of&#xD;
      exercises. The program has six lessons, together lasting for six weeks. Patients are given&#xD;
      the opportunity to exercise at home, without the use of treatment resources and without&#xD;
      spending time traveling to the treatment site. Patients will have access through their&#xD;
      general practitioner or health institution at no extra cost. If it turns out that the program&#xD;
      works according to the intention, the investigators will be able to offer VR to a large&#xD;
      number of PPPS patients who previously would not receive treatment for their condition.&#xD;
&#xD;
      The aim of the pilot study is to find out if the internet program for PPPS works as intended&#xD;
      and evaluate incoming data and make changes to the program. In addition, the investigators&#xD;
      will gain experience in using the program before designing a randomized clinical trial (RCT).&#xD;
      The aim of such an RCT would be to compare this internet based treatment to traditional&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">February 9, 2021</completion_date>
  <primary_completion_date type="Actual">February 9, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Consecutively recruited at Department of Neurology at Molde County hospital, outpatient clinic.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>user experience ease of use</measure>
    <time_frame>3 months</time_frame>
    <description>semi-structured conversation interview with score tools. The ease of use of the course will be scored in a 7 question questionnaire, rated 1-7 from very good to very bad. The questions are whether the program worked well, was boring, if it was the right dose of exercises, if the text was understandable, instructive, how was the yield and degree of subjective improvement. Participants will also be asked for preparation suggestions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom change</measure>
    <time_frame>3 months</time_frame>
    <description>The Niigata persistent positional perceptual dizziness (PPPD) Questionnaire (NPQ) contains 12 questions in which patients answer questions about provocation from three aggravating factors of PPPD (upright posture / gait, movement and visual stimulation). Each factor is evaluated using questions that score the severity from 0 (none) to 6 (unbearable) ailments</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom change</measure>
    <time_frame>3 months</time_frame>
    <description>VSS - vertigo symptom score form. Consists of 15 questions. Each answer is scored on a 5-point scale (0-4), and a measure of the severity of the symptoms is obtained by summing. The total score ranges from 0-60, higher scores indicate more serious problems. Severe dizziness is defined as ≥ 12 points on the total scale. The scale includes two subscales: 8 selected questions related to vertigo and balance (score ranging from 0-32), and 7 selected questions related to autonomic anxiety symptoms (score ranging from 0-28)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Vertigo</condition>
  <arm_group>
    <arm_group_label>Follows the internet-based self-help program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-based self-help program</intervention_name>
    <description>The program is divided into six short weekly lessons providing information about chronic dizziness and vestibular rehabilitation, and demonstrating the exercises by video. The program is freely available in the Norwegian electronic handbook for physicians (NEL). The participants in the study will receive the internet address after inclusion in the study.</description>
    <arm_group_label>Follows the internet-based self-help program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Satisfy diagnostic criteria for persistent positional perceptual dizziness (PPPS) or&#xD;
             satisfy criteria with a duration of &lt;3 months&#xD;
&#xD;
          -  Vertigo symptom scale (VSS-SF) &gt;12&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive dysfunction that is so pronounced that it will make participation difficult&#xD;
&#xD;
          -  Unable to read, understand Norwegian&#xD;
&#xD;
          -  Severe medical or psychiatric illness (including substance abuse) that reduces the&#xD;
             patient's ability to follow the VR program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Torstein Hole, md phd</last_name>
    <role>Study Director</role>
    <affiliation>Møre og Romsdal Hospital Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Molde sykehus</name>
      <address>
        <city>Molde</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Telerehabilitation</keyword>
  <keyword>Internet</keyword>
  <keyword>Norway</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Dizziness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04458376
org study id: 137107
nct id: NCT04458376
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic dizziness,or persistent positional perceptual dizziness (PPPS) is a common condition
      that results in impaired quality of life and work ability of those affected. Vestibular
      Rehabilitation (VR) is an evidence-based and recommended treatment for chronic dizziness. The
      treatment involves training in specific exercises that challenge the balance system and
      eventually improve dizziness. The main challenge with this treatment is that it is usually
      best provided with individual follow-up of therapists trained in the method. Limited
      resources and the lack of dissemination of this knowledge mean that only a minority of
      patients receive adequate treatment. An internet-based self-help program in vestibular
      rehabilitation has been developed in Norwegian with demonstration and instructions of
      exercises. The program has six lessons, together lasting for six weeks. Patients are given
      the opportunity to exercise at home, without the use of treatment resources and without
      spending time traveling to the treatment site. Patients will have access through their
      general practitioner or health institution at no extra cost. If it turns out that the program
      works according to the intention, the investigators will be able to offer VR to a large
      number of PPPS patients who previously would not receive treatment for their condition.

      The aim of the pilot study is to find out if the internet program for PPPS works as intended
      and evaluate incoming data and make changes to the program. In addition, the investigators
      will gain experience in using the program before designing a randomized clinical trial (RCT).
      The aim of such an RCT would be to compare this internet based treatment to traditional
      treatment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Consecutively recruited at Department of Neurology at Molde County hospital, outpatient clinic.
primary purpose: Treatment
masking: None (Open Label)
measure: user experience ease of use
time frame: 3 months
description: semi-structured conversation interview with score tools. The ease of use of the course will be scored in a 7 question questionnaire, rated 1-7 from very good to very bad. The questions are whether the program worked well, was boring, if it was the right dose of exercises, if the text was understandable, instructive, how was the yield and degree of subjective improvement. Participants will also be asked for preparation suggestions.
measure: Symptom change
time frame: 3 months
description: The Niigata persistent positional perceptual dizziness (PPPD) Questionnaire (NPQ) contains 12 questions in which patients answer questions about provocation from three aggravating factors of PPPD (upright posture / gait, movement and visual stimulation). Each factor is evaluated using questions that score the severity from 0 (none) to 6 (unbearable) ailments
measure: Symptom change
time frame: 3 months
description: VSS - vertigo symptom score form. Consists of 15 questions. Each answer is scored on a 5-point scale (0-4), and a measure of the severity of the symptoms is obtained by summing. The total score ranges from 0-60, higher scores indicate more serious problems. Severe dizziness is defined as ≥ 12 points on the total scale. The scale includes two subscales: 8 selected questions related to vertigo and balance (score ranging from 0-32), and 7 selected questions related to autonomic anxiety symptoms (score ranging from 0-28)
arm group label: Follows the internet-based self-help program
arm group type: Experimental
intervention type: Behavioral
intervention name: Internet-based self-help program
description: The program is divided into six short weekly lessons providing information about chronic dizziness and vestibular rehabilitation, and demonstrating the exercises by video. The program is freely available in the Norwegian electronic handbook for physicians (NEL). The participants in the study will receive the internet address after inclusion in the study.
arm group label: Follows the internet-based self-help program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Torstein Hole, md phd
role: Study Director
affiliation: Møre og Romsdal Hospital Trust
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Dizziness