Factors Affecting Outcome of Vestibular Rehabilitation

March 14, 2022 updated by: Guy's and St Thomas' NHS Foundation Trust

Analysis of Illness Perceptions Affecting the Outcome of Vestibular Rehabilitation

This is an observational longitudinal study to investigate if negative illness perceptions predict less improvement in dizziness handicap following vestibular rehabilitation. Consecutive patients (n=260) who enter the vestibular rehabilitation programme at Guy's Hospital, London will be included. Questionnaires will be conducted immediately before, and after their final treatment. The main outcome will be the Dizziness Handicap Inventory after rehabilitation.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The aim of this longitudinal study is to investigate whether illness perceptions predict dizziness handicap following a treatment as usual 8-week vestibular rehabilitation programme in patients with chronic vertigo and dizziness.

Participants will be recruited consecutively from patients attending the dizziness and balance exercise programme at Guys & St Thomas' NHS Foundation Trust. Consenting patients will complete the following questionnaires before and after rehabilitation:

  1. The Dizziness Handicap Inventory (DHI)
  2. The Illness Perceptions Questionnaire - Revised (IPQ-R)
  3. The Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

The Dizziness Handicap Inventory (DHI) at discharge will be the dependent variable. We will also demographic data including age, gender, and illness type.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's & St Thomas' NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with dizziness and balance disorders.

Description

Inclusion Criteria:

  • are aged above 18 years old and are enrolled onto the vestibular rehabilitation programme due to chronic dizziness

Exclusion Criteria:

  • Patients will be excluded if they have evidence of central nervous system disorders or cannot speak English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dizzy group
Patients attending the dizziness and balance exercise programme at Guy's Hospital, London. Patients data will be included if they complete at least 4 sessions.
Behavioral: Vestibular rehabilitation
Vestibular rehabilitation (treatment as usual).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Inventory (DHI)
Time Frame: At discharge (final session of physiotherapy), an average of 10 weeks
DHI at discharge (controlling for baseline DHI in the final analysis). The DHI measures the perceived physically, functionally, and emotionally handicapping effects of dizziness although the total score will be used in this study. It consists of 25 questions, for example "Does walking down the aisle of a supermarket increase your problem?", and participants rate either 'Yes', 'No', or 'Sometimes'. The maximum score is 100 and higher scores represent higher levels of disability and activity restriction.
At discharge (final session of physiotherapy), an average of 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: David Herdman, Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2019

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 269318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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