NSAA NON-Interventional Study Protocol

Red Nucleus Enterprise Solutions, LLC31 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Duchenne Muscular Dystrophy

Interventions

Remote Administration of NSAAOTHER

Remote Administration of NSAA

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Confirmed diagnosis of DMD 3. Participant with DMD aged 4 to12 (inclusive) at t Enrollment date 4. Participant with DMD is ambulatory without assistive devices, braces, or aids throughout the study 5. Caregiver has access to and/or willingness to learn use of a smart phone and the iTC study mobile application 6. Participant and caregiver are based in the US throughout study 7. Participant and caregiver are fluent in the English language (verbally and in writing) Exclusion Criteria: 1. Non-ambulatory DMD participant at any study timepoint 2. Caregiver/participant unwilling or unable to administer/perform the NSAA 3. Anticipated deterioration of participant's ambulatory status during the study

Locations (1)

Red Nucleus Solutions

Malvern, Pennsylvania, United States

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

Data from ClinicalTrials.gov

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