NCT05657938

Evaluation of Home Based Assessments on Participants With DMD

A Phase 0 Study to Evaluate the Clinical Readiness of a Wearable Sensor Device and Duchenne Video Assessment in the Home Environment on Participants With Duchenne Muscular Dystrophy (DMD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Solid Biosciences Inc. · Industry
• Sex: Male
• Age: 4 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DEVICE	Wearable Device	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.
OTHER	Duchenne Video Assessment (DVA)	The DVA is a standardized tool that documents and assesses compensatory movement strategies as a marker of quality of movement.

Timeline

• Start date: 2022-10-13
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2022-12-20
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States