Use of Telemedicine and At-Home Video for Remote Administration of the North Star Ambulatory Assessment (NSAA): a Feasibility Study

Red Nucleus Enterprise Solutions, LLC1 site in 1 country31 target enrollmentOctober 2, 2023

ConditionsDuchenne Muscular Dystrophy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Duchenne Muscular Dystrophy
Sponsor: Red Nucleus Enterprise Solutions, LLC
Enrollment: 31
Locations: 1
Primary Endpoint: Comparison of performance and ratings of the NSAA using three methods: 1) Live Telemedicine scores 2) Subsequent Recorded Telemedicine scores 3) Caregiver Asynchronous Video scores
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this non-interventional study is to evaluate the feasibility of remotely administering the North Star Ambulatory Assessment (NSAA) to participants with Duchenne muscular dystrophy (DMD). The iTakeControl (iTC) software platform will be utilized to remotely administer and score the NSAAs.

Registry

clinicaltrials.gov

Start Date

October 2, 2023

End Date

March 13, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Red Nucleus Enterprise Solutions, LLC

Responsible Party

Principal Investigator

Christopher Jones, PhD

Principal Investigator

Red Nucleus Enterprise Solutions, LLC

Eligibility Criteria

Inclusion Criteria

•Evidence of a signed and dated informed consent document indicating that the participant's legally authorized representative (LAR) has been informed of all pertinent aspects of the study, along with evidence of age-appropriate child assent.
•Confirmed diagnosis of DMD
•Participant with DMD aged 4 to12 (inclusive) at t Enrollment date
•Participant with DMD is ambulatory without assistive devices, braces, or aids throughout the study
•Caregiver has access to and/or willingness to learn use of a smart phone and the iTC study mobile application
•Participant and caregiver are based in the US throughout study
•Participant and caregiver are fluent in the English language (verbally and in writing)

Exclusion Criteria

•Non-ambulatory DMD participant at any study timepoint
•Caregiver/participant unwilling or unable to administer/perform the NSAA
•Anticipated deterioration of participant's ambulatory status during the study

Outcomes

Primary Outcomes

Comparison of performance and ratings of the NSAA using three methods: 1) Live Telemedicine scores 2) Subsequent Recorded Telemedicine scores 3) Caregiver Asynchronous Video scores

Time Frame: 6 Months