Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06153108

Enrollment

Registered

2023-12-01

Start date

2023-11-16

Completion date

2028-02-01

Last updated

2026-06-29

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

Conditions

Inclusion Body Myositis

Keywords

Biomarker

Brief summary

Inclusion-Body Myositis (IBM) results in weakness and the deterioration of distal arm muscles, the symptoms of which are currently assessed through expert examination at clinical visits. Such in-clinic assessments are time-consuming, subjective, of limited sensitivity, and only provide a snapshot of a patient's disease. In this project, the investigators will conduct clinical validation of monitoring digital biomarkers of upper limb function during activities of daily living using a wearable sensor platform that enables frequent, at-home monitoring of upper limb function health in IBM and could be incorporated into IBM trials.

Interventions

DEVICEPAMSys pendant PAMSys wrist sensors

The PAMSysTM sensor consists of a 3-axis accelerometer, battery, and built-in memory for recording long-term data. Accelerometer data is recorded at a sampling frequency of 50 Hz

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Inclusion criteria

1. Meet any of the European Neuromuscular Centre Inclusion Body Myositis research diagnostic criteria 2011 categories for IBM. 2. Able to provide informed consent.

Exclusion criteria

1. Unwillingness to follow study procedures. 2. Participation in an investigational drug research study within the past 30 days.

Design outcomes

Primary

Measure	Time frame	Description
Investigate validity of PAMSys wrist sensor and pendant sensor as monitoring biomarker of upper and lower limb function and physical activity, including leg function, change in IBM patients.	Baseline, Month 6, Month 12	will investigate if sensor-derived parameters measured by the PAMSys wrist sensors and pendant sensor can quantify disease severity and track subtle changes in upper and lower limb health and ambulation over time.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMazen Dimachkie, MD

University of Kansas Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026