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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04391673
Other study ID # 269318
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 26, 2019
Est. completion date September 2023

Study information

Verified date March 2022
Source Guy's and St Thomas' NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2023
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Vestibular rehabilitation
Vestibular rehabilitation (treatment as usual).

Locations

Country Name City State
United Kingdom Guy's & St Thomas' NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dizziness Handicap Inventory (DHI) 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
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