This study is designed to evaluate the feasibility, wearability and participant satisfaction of novel outcome assessment tools in DMD patients which are performed in the home environment.
This is a low interventional feasibility study to evaluate the use of: 1. An FDA 510(k) cleared Class II wearable medical device designed to collect medical grade, clinical quality biometric, physiological and other electronic clinician outcome assessments data in a clinical trial setting, and; 2. The Duchenne Video Assessment (DVA) tool to evaluate the quality of movement in patients with Duchenne Muscular Dystrophy (DMD) This study will provide data on suitability of these tools in future clinical trials.
Study Type
OBSERVATIONAL
Enrollment
17
The wearable device used in this study is an FDA 510(k) cleared Class II medical device designed to collect medical grade, clinical quality biometric, physiological and other electronic clinician outcome assessments data in a clinical trial setting. The system processes raw data into recognizable clinical metrics including vital signs, activity and posture classifications, surface electromyography (sEMG), and sleep metrics. The sensors are multi-modal, multilocation, rechargeable and reusable.
The DVA is a standardized tool that documents and assesses compensatory movement strategies as a marker of quality of movement.
Solid Biosciences
Charlestown, Massachusetts, United States
Wearable sensor device compliance
The wearable sensor device is composed of three small sticker-based sensors that are worn on the chest, thigh and ankle to record activity. Participants will wear the sensors during specified periods over the study duration and compliance will be assessed based on recorded activity.
Time frame: 30 days
Accuracy of functional evaluation using the Duchenne Video Assessment (DVA) tool in an at-home setting
The DVA is a digital tool designed to remotely evaluate functional capacity in a natural environment. Participants will complete a set of movement tasks at specified timepoints during the study that will be captured on video and scored by remote evaluators. DVA scoring will be compared with anticipated levels of functional capacity to assess accuracy.
Time frame: 30 days
Preference for use of the wearable sensor device and DVA tool as assessed by interview
Participants will be asked to complete an exit interview at the conclusion of the study to assess user preference.
Time frame: Day 24-30
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