Multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
People with multiple sclerosis (n=100) and healthy controls (n=30) will attend two visits interspersed by a 2-3-week home monitoring period. Participation will occur after providing informed written c
MS type and duration of condition, medical history and current medication
2. Standardised neurological examination using the Expanded Disability Status Scale
3. Assessment of hand function using the 9
cognition and walking and balance. The finger coordination tests (pinching and drawing) and cognition test for processing speed require the participants to interact with the app (e.g. undertaking a di
Sponsors
Roche (Switzerland)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: People with multiple sclerosis must meet the following criteria for study entry: 1. Signed informed consent form 2. Able to comply with the study protocol, in the investigator’s judgement 3. Confirmed diagnosis of MS, according to McDonald criteria 2010 or 2017 4. Currently untreated or treated with an approved or off-label disease-modifying treatment 5. Age 18-70 years (inclusive) 6. Body mass index (BMI) <35 kg/m² 7. Ambulatory patients with an EDSS of 0.0-6.5 (inclusive) Patients in the healthy control group must meet the following criteria for study entry: 1. Signed informed consent form 2. Able to comply with the study protocol, in the investigator’s judgement 3. Age 18-70 years (inclusive) 4. BMI <35 kg/m² 5. No ambulatory limitation, according to investigator's assessment (i.e., no use of walking aids, no musculoskeletal, vision, vestibular, cardiovascular or neurological deficits that could impair gait)
Exclusion criteria
Exclusion criteria: People with Multiple Sclerosis who meet any of the following criteria will be excluded from study entry: Clinical relapse in the past 60 days Treatment with fampridine/dalfampridine (Fampyra®)/Ampyra®) or other symptomatic MS treatment unless on stable dose for =30 days prior to screening (if dose changes are expected in the course of the observation period, patient should not be enrolled) Change in rehabilitation protocol in the previous 60 days and during the study period Treatment initiation with a DMT expected to occur in the course of the observation period for patients who are untreated at screening Recovering from an infection or an intercurrent illness that may interfere with balance and gait according to the investigator’s judgment Uncorrected vision, musculoskeletal problems, marked vestibular deficits not caused by MS (e.g., benign paroxysmal positional vertigo [BPPV], Meniere's disease, previous diagnosed peripheral nerve dysfunction) or other non-MS neurological problems, that may interfere with balance and gait according to the investigator’s judgment Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Step intensity measured while walking using smartphone-based inertial data and 3D motion analysis at visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/09/2021: Walking related measures 1. Walking speed measured using smart-phone based accelerometers and inertial sensors during the 2 minute walking test and 25 foot walking test in visit 1 2. Walking speed measured using smart-phone based accelerometers, 3D motion analysis, and inertial sensors when walking at self selected and maximal walking speed and undertaking a secondary task (subtracting serial 7s, termed dual task) on a treadmill or during overground walking at visit 3 (U turn test and 25 m walking test) and during overground walking (2 minute walk test and minimum 15 mins walking) in the home based environment on 14 consecutive days 3. Cadence measured using smart-phone based accelerometers and 3D motion analysis when walking at self selected and maximal walking speed and undertaking a secondary task (subtracting serial 7s, termed dual task) on a treadmill or during overground walking (U turn test and 25 m walking test) at visit 3 and during overground walking (2 minute walk test and minimum 15 mins walking) in in the home based environment on 14 consecutive days 4. Step and stride length measured using smart-phone based accelerometers and 3D motion analysis when walking at self selected and maximal walking speed and undertaking a secondary task (subtracting serial 7s, termed dual task) on a treadmill or during overground walking (U turn test and 25 m walking test) at visit 3 and during overground walking in the home based environment (2 minute walk test and minimum 15 mins walking) in on 14 consecutive days 5. Step and stride time measured using smart-phone based accelerometers and 3D motion analysis when walking at self selected and maximal walking speed and undertaking a secondary task (subtracting serial 7s, termed dual task) on a treadmill or during overground walking (U turn test and 25 m walking test) at visit 3 and during overground walking in the home based environment (2 minute walk test and minimum 15 m | — |
Countries
England, United Kingdom
Outcome results
None listed