Clinical trial NCT06937723: Smart Monitoring Assessing Spasticity-related Health
Official title: Smart Monitoring Assessing Spasticity-related Health - A Prospective Multiple Sclerosis Study With Wearables
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Spasticity
Smartwatch
Wearables
Digital health tools
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MS and 18 years or older

Brief summary: This observational study seeks to investigate the underlying of spasticity in patients with multiple sclerosis (MS) by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, the investigators aim to evaluate whether digital measurements are suitable for monitoring spasticity-related everyday limitations and to compare them with established clinical scores, blood analyses and questionnaires including sores on quality of life, sleep quality or activities of daily living.

Detailed description: The symptomatic treatment of spasticity in patients with multiple sclerosis (MS) is a major challenge for both patients and healthcare providers. However, monitoring and measuring the success or failure of treatments in clinical practice remains difficult. This is mainly due to the lack of clinical scores and biomarkers that can be easily and longitudinally collected. Existing scores (such as questionnaires and the Modified Ashworth scale) are rarely used in practice. In addition, the monitoring of side effects (such as dizziness, nausea and fatigue) is difficult in routine clinical practice and often leads to premature discontinuation or switching of treatment. As a result, therapeutic options are often exhausted prematurely. Continuous monitoring with sensitive assessments could enable a better understanding of spasticity treatment.

Approximately 50 patients with moderate and severe spasticity due to MS are to be included in the study. After inclusion, follow-up examinations are carried out every 12 weeks; a total of 3 visits are planned, including the baseline examination.

The study aims to improve the understanding of spasticity symptoms and assess them in patients through multimodal clinical and longitudinal digital measurements.

Eligibility criteria: Inclusion Criteria:

Patients must meet all the following criteria to be eligible to participate in the study:

* ≥ 18 years of age
* Diagnosis of multiple sclerosis according to the McDonald criteria of 2017
* Presence of spasticity that requires medical treatment from a medical point of view
* own and use a smartphone with Android 8.1 (or higher version) or iOS 12.3 (or higher version)
* Able to operate a smartphone

Exclusion Criteria:

* Missing informed consent
* Lack of declaration of consent
* Unwillingness or inability to use the smartphone app
* Any comorbidity that leads to impaired understanding or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. The decision will be made at the discretion of the investigators.

Primary outcomes:
measure: Wearing time of smartwatch (daily)
timeFrame: 180 days
measure: Longitudinal development of activity parameter: step count
timeFrame: 180 days
measure: Longitudinal development of activity parameter: approximate distance traveled (meter)
timeFrame: 180 days
measure: Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings Description: Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television
timeFrame: 180 days
measure: Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings Description: Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton
timeFrame: 180 days
measure: Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings Description: Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football, baseball, or tennis (singles)
timeFrame: 180 days
measure: Longitudinal development of activity parameter: sum of all active time (seconds)
timeFrame: 180 days
measure: Longitudinal development of activity parameter: approximate calories burned Time
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time awake (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: number of times user woke up
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time to sleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: total time in bed (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: total time asleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: ratio of sleep/time in bed
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: Withings Sleep score Description: Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: average heartrate
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: maximal heartrate
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: minimum heartrate
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds) Description: Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds) Description: Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds) Description: Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds) Description: Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate
timeFrame: 180 days
measure: The Modified Ashworth Scale (MAS)
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
Secondary outcomes:
measure: WHOQoL-BREF (World Health Organization Quality of Life Questionnaire Brief Version)
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
measure: The Expanded Disability Status Scale (EDSS)
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
measure: Smartwatch Questionnaire
timeFrame: 6 months (V3)
measure: End of Dose Questionnaire (EOD)
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
measure: McCorkle and Young Symptom Distress Scale
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
measure: The Multiple Sclerosis Impact Scale 29 (MSIS-29)
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
measure: The Numeric Rating Scale (NRS)
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
measure: The Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
measure: The Edmonton Symptom Assessment Scale (ESAS)
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
measure: Sleep-Questionnaire
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
measure: EQ-5D-5L
timeFrame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Medical Faculty, Heinrich-Heine-University
state: Northrhine-Westphalia
Study officials:
References: