An exploratory, non-interventional study to biotype patients with facioscapulohumeral muscular dystrophy (FSHD) and controls using digital technologies

An exploratory, non-interventional study to biotype patients with facioscapulohumeral muscular dystrophy (FSHD) and controls using digital technologies - Digital biotyping of FSHD patients and controls.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48191

Enrollment

Registered

2019-03-29

Start date

2019-04-18

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FSHD

Interventions

None listed

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: * FSHD patients: Genetically confirmed FSHD. Symptomatic, as demonstrated by Lamperti score >0. Android-based smartphone with Android version 5.0 or higher. Age 16+ years.;* Controls: Unrelated subjects without FSHD. Android-based smartphone with Android version 5.0 or higher. Age 16+ years.

Exclusion criteria

Exclusion criteria: * FSHD patients: Inability to give consent. Current or previously diagnosed illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study.;* Controls: Inability to give consent. Current or previously diagnosed illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study.

Design outcomes

Primary

Measure	Time frame
* Patients and controls will be characterized using the following data as collected by digital technologies: o Social activity - Voice activation (probability of human voices in proximity) - Phone (length of call, last 3 digits of phone number, number known/unknown) - SMS (amount of characters, last 3 digits of phone number, number known/unknown) - App usage (categories of apps, start time, running in background/foreground) - Light sensor (lm) o Physical activity - Acceleration - Gyroscope - Magnetic field - Step count - Google Places - Relative location o Biometric data collected using the Withings Health platform: - Withings Steel HR smartwatch * Sleep pattern (time of sleep, sleep phases) * Heart rate data * Physical activity (steps, walking distance) - Withings Body+ scale * Weight (kg) * Body composition (%) - Withings Blood Pressure Monitor * Systolic blood pressure (mmHg) * Diastolic blood pressure (mmHg) * User experience and subjective burden of the smartphone-based technologies will be assessed with a questionnaire. * Clinical severity of FSHD (by Lamperti Score) * Physical mobility (by Timed Up-and-Go Test)	—

Measure

Time frame

* Patients and controls will be characterized using the following data as collected by digital technologies: o Social activity - Voice activation (probability of human voices in proximity) - Phone (length of call, last 3 digits of phone number, number known/unknown) - SMS (amount of characters, last 3 digits of phone number, number known/unknown) - App usage (categories of apps, start time, running in background/foreground) - Light sensor (lm) o Physical activity - Acceleration - Gyroscope - Magnetic field - Step count - Google Places - Relative location o Biometric data collected using the Withings Health platform: - Withings Steel HR smartwatch * Sleep pattern (time of sleep, sleep phases) * Heart rate data * Physical activity (steps, walking distance) - Withings Body+ scale * Weight (kg) * Body composition (%) - Withings Blood Pressure Monitor * Systolic blood pressure (mmHg) * Diastolic blood pressure (mmHg) * User experience and subjective burden of the smartphone-based technologies will be assessed with a questionnaire. * Clinical severity of FSHD (by Lamperti Score) * Physical mobility (by Timed Up-and-Go Test)

—

Secondary

Measure	Time frame
Same as the primary endpoints	—

Countries

Netherlands

Outcome results