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

NCT06153108 | Active Not Recruiting

• 1 other identifier: Biosensics IBM
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Inclusion Body Myositis

Keywords

Biomarker

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline, Month 6, Month 12

Interventions

PAMSys pendant PAMSys wrist sensors DEVICE

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with diagnosed inclusion body myositis

You may qualify if:

• Able to provide informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• BioSensics: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Myositis, Inclusion Body

Condition Hierarchy (Ancestors)

Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Mazen Dimachkie, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: November 16, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (1)