Smart Monitoring Assessing Spasticity-related Health

Condition(s) studied

Investigational drug(s) / intervention(s)

Device: Smartwatch (Withings Scanwatch): All-day monitoring of patients via smartwatch

Study 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.

Eligibility

Primary outcome measure(s)

• Wearing time of smartwatch (daily) — 180 days
• Longitudinal development of activity parameter: step count — 180 days
• Longitudinal development of activity parameter: approximate distance traveled (meter) — 180 days
• 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 — 180 days
• 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 — 180 days
• 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) — 180 days
• Longitudinal development of activity parameter: sum of all active time (seconds) — 180 days
• Longitudinal development of activity parameter: approximate calories burned Time — 180 days
• Longitudinal development of sleep parameter: time awake (seconds) — 180 days
• Longitudinal development of sleep parameter: number of times user woke up — 180 days
• Longitudinal development of sleep parameter: time to sleep (seconds) — 180 days
• Longitudinal development of sleep parameter: total time in bed (seconds) — 180 days
• Longitudinal development of sleep parameter: total time asleep (seconds) — 180 days
• Longitudinal development of sleep parameter: ratio of sleep/time in bed — 180 days
• Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds) — 180 days
• Longitudinal development of sleep parameter: time awake after first falling asleep (seconds) — 180 days
• 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 — 180 days
• Longitudinal development of cardiovascular parameter: average heartrate — 180 days
• Longitudinal development of cardiovascular parameter: maximal heartrate — 180 days
• Longitudinal development of cardiovascular parameter: minimum heartrate — 180 days
• 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. — 180 days
• 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. — 180 days
• 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. — 180 days
• 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 — 180 days
• The Modified Ashworth Scale (MAS) — Screening + Baseline (V1), 3 months (V2), 6 months (V3)
  The Modified Ashworth Scale (MAS) is a clinical tool for assessing muscle spasticity in patients, particularly those with neurological conditions such as multiple sclerosis (MS). It assesses the resistance of a muscle to passive stretching and thus measures the degree of spasticity. The MAS helps to assess the severity of spasticity and monitor the effectiveness of treatment and disease progression. The scale ranges from 0 (no increased muscle tone) to 5 (limbs rigid in flexion and extension).

Trial sites (1)

More Heinrich-Heine University, Duesseldorf trials in Germany

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