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

Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04458376
• Other study ID #: 137107
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: February 9, 2021

Study information

• Verified date: February 2021
• Source: Helse Møre og Romsdal HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 9, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Vertigo

Intervention

Behavioral:
• Internet-based self-help program
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.

Locations

Country	Name	City	State
Norway	Molde sykehus	Molde

Sponsors (1)

Lead Sponsor	Collaborator
Helse Møre og Romsdal HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	user experience ease of use	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.	3 months
Primary	Symptom change	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 months
Primary	Symptom change	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)	3 months