VEstibular Rehabilitation in MultIple Sclerosis
VEstibular Rehabilitation in MultIple Sclerosis: a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for Benign Paroxysmal Positional Vertigo.
What it found
A paper reports the results; we have not read it yet. See Papers below.
What it measured
Main measures
Primary outcome measure for trial 1 (interventional study): Impact of dizziness on daily life (functionally, emotionally and physically), assessed using the Dizziness Handicap Inventory (DHI) questionnaire at the baseline, after 14 weeks and after 26 weeks Primary outcome measure for trial 2 (observational study): Presence of BPPV as assessed using the Dix-Hallpike test and the log roll test at
Other measures (1)
Secondary outcome measures for trial 1 (interventional study) -t he following will be assessed at the baseline, after 14 weeks and after 26 weeks unless otherwise stated: 1. Impact of multiple sclerosis (MS) on walking using the 12-item Multiple Sclerosis Walking Scale (MSWS-12) 2. Perceived confidence in performing 16 activities of daily living, assessed using the Activities-Specific Balance Conf
VisionThinking and memoryFatigueWalking and mobilityPhysical functionPainMood and sleepQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over · EDSS 2 to 6.5
Show the full criteria
Inclusion criteria
Inclusion: 1. Diagnosis of MS according to revised McDonald criteria 2. Patient determined disease steps 1-5, equivalent to Expanded Disability Status Scale (EDSS) 2-6.5 3. Reporting one of the following at least 4 times per month (questions 1, 7 and 18 on the Vertigo Symptom Scale (VSS)): 3.1. Feeling that things are spinning or moving around 3.2. Feeling of being light-headed, “swimmy” or giddy 3.3. Feeling unsteady and about to lose balance 4. Aged 18 years or older 5. Willing and able to travel to and participate in the 12 face to face sessions should they be allocated to the customised face to face treatment group of the randomised controlled trial, and to commit to undertaking their individualised home-based programme 6. Willing and able to travel to local assessment centres for blinded outcomes assessment People will be firstly screened for the presence of BPPV. Those with BPPV will be entered into the observational trial (trial 2). The remaining participants will be screened for the presence of central or peripheral vestibulopathy. Those with central and/or peripheral vestibulopathy will be entered into the randomised controlled trial (trial 1). Exclusion: 1. Neurological conditions other than MS as determined from clinical notes 2. Relapsed/received steroid treatment within the last month 3. Currently or recently (within past six months) participated in a VR Program 4. Orthopaedic deficit which may on impact on postural and gait testing or significant pain or weakness (> 4/10 on a numerical rating scale) associated with osteo- or rheumatoid arthritis 5. Dizziness solely explained by other causes (e.g. postural hypotension) 6. Headache or migraine associated with a subjective report of one of the following at least 4 times per month: 6.1. Nausea (feeling sick) or stomach churning 6.2. Vomiting 7. People who have been taking vestibular sedatives specifically for the treatment of vertigo for more than 4 weeks. Vestibular sedatives impair the vestibular compensation process that occurs with rehabilitation (53). Therefore we will ask people on vestibular sedatives to stop their medication for the testing and trial. We will inform people’s GP and neurologist about this advice. Medications such as prochlorprazine can also reduce migraines and so there can be a rebound migraine when such medications are withdrawn following chronic use (> 1 month). Therefore people who have been taking vestibular sedatives for more than 1 month will be excluded. If people have been chronically taking vestibular sedatives (> 1 month) and, with approval of their neurologist and/or GP they stop the medication then they will be eligible to take part in the study after a 6 week wash out period.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims Symptoms of dizziness or vertigo in multiple sclerosis (MS) can be caused by problems with the inner ear (termed vestibular system), in the signalling in the nerves supplying the vestibular system and in processing of signals in the brain. It is currently unclear in people with multiple sclerosis whether available treatments are effective and whether symptom relief lasts after cessation of treatment. This study aims to compare the clinical and cost-effectiveness of a 12-week customised home-based rehabilitation program with a home-based program delivered via a generic standard format exercise booklet in people with MS (pwMS) and peripheral or central vestibulopathy. A secondary study will explore whether people with MS with another inner ear disorder caused by dislodged crystals in the inner ear (termed benign paroxysmal positional vertigo or BPPV) respond to repositioning manoeuvres and whether the symptoms re-occur over the next 12 months. Who can participate? Adults with multiple sclerosis who can walk at least 20 m and have symptoms of dizziness or vertigo What does the study involve? Participants with difficulties in processing how inner ear (vestibular signals) are processed in the peripheral nerves or in the brain will be entered after screening into a trial. Participants will be randomly allocated to one of two groups. Group 1 will receive customised exercises, involving a 12 week home programme of exercises targeting specific problems, supplemented by 12 face-to-face sessions with a physiotherapist. Group 2 will receive generic exercises, involving a 12 week home programme of exercises from a booklet and 2 telephone calls with a physiotherapist. Measures, which will include questionnaires, diaries and interviews will be taken at the start and end of the study, in order to assess symptoms, balance and walking, cost and effectiveness. Participants with evidence of BPPV will be treated with an appropriate repositioning manoeuvre with up to 3 sessions. The success rate of the repositioning manoeuvres will be measured and the re-occurrence rate if symptoms monitored over 12 months. What are the possible benefits and risks of participating? The possible benefit of participating is that the booklet-based or customised-based exercise programs for dizziness could both reduce symptoms of dizziness and imbalance. However, a possible risk is that the tests may cause fatigue and muscle soreness. The tests and treatment will bring on people’s symptoms. This is required to diagnose and then treat the condition. The treatments will challenge participants' balance. There is a risk of falling but the therapist will ensure that people are safe when exercising. Where is the study run from? Plymouth Hospitals NHS Trust and 3 other sites in the UK When is the study starting and how long is it expected to run for? July 2018 to September 2021 Who is funding the study? The Multiple Sclerosis Society (Joint Physiotherapy Research Foundation) (UK) Who is the main contact? Jonathan Marsden jonathan.marsden@plymouth.ac.uk
Papers
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History
Started
Nov 2018
Finished
Sept 2021