Smart Monitoring Assessing Spasticity-related Health
Recruiting · NCT06937723 · Observational (researchers observe without assigning treatment) · Lead sponsor: Heinrich-Heine University, Duesseldorf
View the official record on ClinicalTrials.gov →Interventions studied
Device: Smartwatch (Withings Scanwatch)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Medical Faculty, Heinrich-Heine-University - Düsseldorf, North Rhine-Westphalia, Germany