ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-16
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06153108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Meet any of the European Neuromuscular Centre Inclusion Body Myositis research diagnostic criteria 2011 categories for IBM.
  2. 2. Able to provide informed consent.
  1. 1. Unwillingness to follow study procedures.
  2. 2. Participation in an investigational drug research study within the past 30 days.

Contacts and Locations

Principal Investigator

Mazen Dimachkie, MD
PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center

Study Locations (Sites)

University of Kansas Medical Center
Kansas City, Kansas, 66160
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Mazen Dimachkie, MD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-16
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-11-16
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Biomarker

Additional Relevant MeSH Terms

  • Inclusion Body Myositis