Validation of smartphone-based assessments in multiple sclerosis

Not Applicable

Completed

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN15993728
• Lead Sponsor: Roche (Switzerland)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-17
• Study Completion: 2023-10-01
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Step intensity measured while walking using smartphone-based inertial data and 3D motion analysis at visit 3