Monitoring physical activity and limb function in Inclusion Body Myositis using wearable sensors
Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time
This study is testing if wearable sensors can help track how well people with Inclusion Body Myositis use their arms and stay active in their daily lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06153108 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the use of digital biomarkers for monitoring upper limb function in patients with Inclusion Body Myositis (IBM) through a wearable sensor platform. By enabling frequent, at-home assessments of physical activity and limb function, the study seeks to provide a more sensitive and continuous measure of disease progression compared to traditional in-clinic evaluations. Participants will wear PAMSys wrist sensors during daily activities, allowing for real-time data collection and analysis. The goal is to improve the understanding of IBM and enhance future clinical trials.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Inclusion Body Myositis who can provide informed consent.
Not a fit: Patients who are unwilling to follow study procedures or have participated in another investigational drug study within the past 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate monitoring of disease progression and better management of Inclusion Body Myositis.
How similar studies have performed: While the use of wearable sensors for monitoring physical activity is gaining traction, this specific application in Inclusion Body Myositis is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Mazen Dimachkie, MD — University of Kansas Medical Center
- Study coordinator: Samantha Colgan, MS
- Email: scolgan@kumc.edu
- Phone: 913-945-9938
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.