Pragmatic randomised controlled trial of nurse-delivered vestibular rehabilitation for dizzy patients in primary care.
| ISRCTN | ISRCTN63019017 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63019017 |
| Protocol serial number | SEO083 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 18/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lucy Yardley
Scientific
Scientific
Department of Psychology
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
| Phone | +44 023 80 594 581 |
|---|---|
| L.Yardley@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare the outcome of nurse-delivered vestibular rehabilitation for dizzy patients in primary care with standard medical care. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ear, nose and throat diseases |
| Intervention | Vestibular rehabilitation programme of daily eye, head and body exercises, education about causes and management of symptoms delivered by nurse therapist versus routine medical care. |
| Intervention type | Other |
| Primary outcome measure(s) |
Computerised measurement of postural sway; validated self-report measures of symptoms and quality of life. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 200 |
| Key inclusion criteria | 200 patients with current dizziness or vertigo of at least 2 months' duration. Current complaint of dizziness or vertigo for which a vestibular cause is a definite or possible diagnosis; telephone ownership. |
| Key exclusion criteria | Age <18 yrs, disorders contraindicating performance of vigorous head/body exercises (vertebrob asilar ischaemia, severe cervical disorder), diagnosed non-vestibular cause of dizziness, life-threatening or progressive central disorder |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Psychology
Southampton
SO17 1BJ
United Kingdom
SO17 1BJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/10/2004 | Yes | No |