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 the execution of cognition and hand motor function tests within the Floodlight program

Roche (Switzerland)0 个研究点目标入组 130 人开始时间: 2021年9月17日最近更新: 2023年11月6日

适应症

试验速览

2023 Protocol article in https://doi.org/10.1177/20552076231205284 (added 23/10/2023)

•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)

•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

发起方

Roche (Switzerland)