A study investigating the possibility and practicality of assessing and treating dizziness after traumatic brain injury

Not Applicable

Completed

Conditions: Benign paroxysmal positional vertigo
Ear, Nose and Throat

Registration Number: ISRCTN91943864

Lead Sponsor: Imperial College London

Brief Summary: 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32944278/ protocol (added 21/09/2020) 2023 Interim results article in https://pubmed.ncbi.nlm.nih.gov/36592999/ Qualitative results on healthcare professionals' perceptions of barriers or facilitators (added 03/01/2023) 2024 Results article in https://doi.org/10.1136/bmjno-2023-000598 (added 31/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 75

Inclusion Criteria

Patient
1. Over the age of 18 years
2. Closed head injury as defined by CT imaging
3. Inpatient on major trauma or outlying ward
4. Able to give informed consent or consultee consent
5. Sufficient grasp of English to consent and complete outcome measures

Staff inclusion criteria:
1. Members of ward staff involved in the trial
2. Able to consent to an audio-recorded interview

Exclusion Criteria

Patients exclusion criteria:
1. History of previous or current substance abuse
2. Orthopaedic or vascular cervical spine instability
3. Pregnant
4.Glasgow Coma Score at assessment less than 14
5. Medically unstable
6. Current prescription of Phenytoin
7. Active psychiatric disease, including those with a current or past history of active psychotic disease but not those with a past history of psychiatric disease

Staff exclusion criteria:
Does not meet inclusion criteria

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Trial recruitment and retention rates measured at the end of the trial<br>2 .Acceptability and fidelity of the intervention examined at the end of the trial<br>3. Incidence of adverse events measured at the end of the trial

Secondary Outcome Measures

Name	Time	Method
1. Frequency of BPPV measured at baseline, 4 and 12 weeks<br>2. Dizziness handicap measured using Dizziness handicap inventory at baseline, 4 and 12 weeks<br>3. Balance confidence measured using the Activities specific balance confidence scale at baseline 4 and 12 weeks<br>4. Mood measured using the hospital anxiety and depression scale at baseline, 4 and 12 weeks<br>5. Static and dynamic balance measured using the mCTSIB and mDGI at baseline and 4 and 12 weeks<br>6. Quality of life measured using quality of life after brain injury questionnaire at 4 and 12 weeks<br>7. Brain injury recovery measured using the glasgow outcome scale extended at 4 and 12 weeks