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Completed

NCT Number: NCT04458376

Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness

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.

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Key information

Conditions

Vertigo Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vestibular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Molde sykehus

Molde, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Satisfy diagnostic criteria for persistent positional perceptual dizziness (PPPS) or satisfy criteria with a duration of <3 months
  • Vertigo symptom scale (VSS-SF) >12

Exclusion criteria

  • Cognitive dysfunction that is so pronounced that it will make participation difficult
  • Unable to read, understand Norwegian
  • Severe medical or psychiatric illness (including substance abuse) that reduces the patient's ability to follow the VR program

Treatment and study plan

Internet-based self-help program

Behavioral

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.

Primary outcomes

  1. user experience ease of use

    Time frame: 3 months

    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.

  2. Symptom change

    Time frame: 3 months

    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

  3. Symptom change

    Time frame: 3 months

    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)

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Registry information

Official study title

Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness; a Pilot Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2020
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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