Smart Monitoring Assessing Spasticity-related Health

NCT06937723 | Recruiting

• 1 other identifier: SMASH_1.0
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Spasticity; Smartwatch; Wearables; Digital health tools

Outcome Measures

Primary Outcomes (25)

• 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)

  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).

  Screening + Baseline (V1), 3 months (V2), 6 months (V3)

Secondary Outcomes (11)

• WHOQoL-BREF (World Health Organization Quality of Life Questionnaire Brief Version)

  Screening + Baseline (V1), 3 months (V2), 6 months (V3)

• The Expanded Disability Status Scale (EDSS)

  Screening + Baseline (V1), 3 months (V2), 6 months (V3)

• Smartwatch Questionnaire

  6 months (V3)

• End of Dose Questionnaire (EOD)

  Screening + Baseline (V1), 3 months (V2), 6 months (V3)

• McCorkle and Young Symptom Distress Scale

  Screening + Baseline (V1), 3 months (V2), 6 months (V3)

Study Arms (1)

MS patients

Patients with Multiple Sclerosis

Other: Device: Smartwatch (Withings Scanwatch)

Interventions

Device: Smartwatch (Withings Scanwatch) OTHER

All-day monitoring of patients via smartwatch

MS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MS and 18 years or older

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Medical Faculty, Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marc Pawlitzki, PD Dr. med.

CONTACT

0049 21181-17889; neuro-trials@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator / PI

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: April 22, 2025
• Study Start: October 19, 2023
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)