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Evaluation of Home Based Assessments on Participants With DMD

NCT05657938 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2023-08-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Solid Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Carl A Morris, PhD · Solid Biosciences

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2023-04-04
Completion
2023-04-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657938 on ClinicalTrials.gov