Validation of Smartphone-based Assessments in Multiple Sclerosis
Research type
Research Study
Full title
An observational study in patients with multiple sclerosis to assess validity and information content of smartphone-based gait and balance features and to qualitatively investigate execution of cognition and hand motor function tests within the Floodlight program
IRAS ID
302099
Contact name
Jonathan/ JF Marsden
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
ISRCTN Number
ISRCTN15993728
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study aims to validate a smartphone based app (Floodlight FL) that aims to monitor symptoms in people with Multiple Sclerosis (MS). The app contains tests of finger coordination, cognition, walking and balance.
Participant with MS (n=75) will be recruited from local neurology clinics. Following informed consent they will undertake two visits interspersed with 2 weeks of home based assessments. People with MS will be compared to 25 healthy controls
On the initial visit clinical researchers will ask about demographics, clinical history and current medication and undertake standardised routine clinical/performance assessments (e.g., EDSS, NHPT). Participants will be shown how to use the smartphone app and also two inertial sensors that can measure walking ability when attached to the shoes. Participants will be supplied with a dedicated phone containing the app and a belt to house the smartphone during the walking and balance tests for the duration of the study.
Over the next 2 weeks participants will be asked to undertake the Floodlight app tests everyday; this will take 10-15 minutes. They will also be asked to carry the phone while walking for at least 15 minutes. At the end of this period participants will complete a booklet of validated questionnaires that ask about their MS symptoms and how they are affected by them.
On the final visit participants' walking and balance will be measured accurately using a 3D motion analysis system (Vicon, UK) while also wearing 6 smartphones worn around the waist or legs. People will be asked to take a series of progressively difficult balance tests, tests of walking at various speeds on a treadmill and tests of walking overground where movement will be measured either using the 3D motion analysis system and/or the shoe worn sensors. A non-identifiable video will be taken of people perfoming the app hand and cognitive tests
Summary of study results:
Multiple Sclerosis (MS) can affect how signals arising from the inner ear are processed. It results dizziness or vertigo and problems with balancing and walking. We studied the rehabilitation of vestibular symptoms in people with Multiple Sclerosis (MS). We diagnosed the vestibular disorder using clinical tests as well as recordings of eye movements while people were rotated in a chair or followed visual targets.
People were randomly allocated to one of the two groups who both undertook training over 12 weeks. In one group training was customised to their difficulties and consisted of up to 12 face-to-face sessions and a home based program. In the other group people were assessed and taught to use a booklet of standardised exercises at home over 12 weeks. They then received telephone support at weeks 1 and 3. People were assessed at baseline, after treatment at 14 weeks and again at 26 weeks on a range of outcome measures.
We recruited to the target of 70 people (35 in each group). Some of this recruitment coincided with the COVID-19 pandemic; this meant that some people in the customised intervention group received their therapy on line. Our analysis of the data did not suggest that this made any marked difference to the result found. The pandemic also meant that could not undertake some of the face to face outcome measures therefore there was less data than anticipated for the final analysis.
The baseline characteristics (such as age, type of MS and vertigo severity) were similar across both groups. The primary outcome was the dizziness handicap inventory (DHI). This is a scale from 0-100 where a higher score indicates a greater impact of dizziness. People rate whether certain movements aggravate symptoms and what is the perceived impact of dizziness on everyday activities, emotions and mood.
We evaluated how much the DHI changed between the baseline assessment and assessment at 26 weeks and whether this change differed between the groups. Both groups showed a decrease in the DHI of 8.7 points on average. There was, however, no difference in the DHI reduction between groups. This was the case when the DHI was assessed immediately after the intervention phase at 14 weeks. This lack of difference between groups was seen regardless of whether we took into account factors such as people’s baseline scores on the DHI, severity of other symptoms and whether they were affected by the COVID-19 pandemic. It suggests that for the primary outcome there was no difference between the two intervention types.Several secondary outcome measures were taken at both 14 and 26 weeks. At week 26 the customised intervention group showed greater improvements in the vertigo symptom severity score; a scale that rates the severity of people’s dizzy symptoms. There were also significant improvements in an objective measure of walking, the dynamic gait index, at both week 14 and 26 in the customised intervention group. This was accompanied by significant improvements in the customised intervention group on a questionnaire asking about people’s confidence when balancing and the perceived impact of their physical symptoms.
We assessed if people attended the face-to-face sessions and whether they undertook home exercises using a diary. We had a high return of the diary sheets. The diaries indicated that a minimal dose of exercise was achieved in 48.6% of the booklet-based group and 71.4% in the customized intervention group. In the customized intervention group 88% attended a minimal of 9 sessions. Overall, the study was deemed to be safe, there were some incidents of neck pain and two non-injurious falls associated with the exercises; this accounted for less than 0.27% of all the falls reported in the study period.
In summary, we found that a customised intervention improved people’s perceived severity of dizziness but there was no difference between customised and booklet-based exercises in the impact of dizziness symptoms. The customised intervention showed significant improvements in measures of balance confidence, walking and in the perceived impact of their physical symptoms.
In addition, as part of the screening process we diagnosed and treated people with a separate vestibular compliant called Benign Paroxysmal Positional Vertigo (BPPV). This occurs when chalk crystals become dislodged in the inner ear causing symptoms when the head turns. BPPV can be treated using manoeuvres that reposition the crystals in the inner ear. We only found one person out of 73 screened (1.4%) with BPPV who we successfully treated. For the first time this suggests that the prevalence of BPPV is similar in MS to the general population.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
22/WM/0028
Date of REC Opinion
31 Mar 2022
REC opinion
Further Information Favourable Opinion