NSAA NON-Interventional Study Protocol

Last updated: March 18, 2025
Sponsor: Red Nucleus Enterprise Solutions, LLC
Overall Status: Completed

Phase

N/A

Condition

Muscular Dystrophy

Treatment

Remote Administration of NSAA

Clinical Study ID

NCT06054971
NSAA-RWE-001
  • Ages 4-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Evidence of a signed and dated informed consent document indicating that theparticipant's legally authorized representative (LAR) has been informed of allpertinent 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 aidsthroughout the study

  5. Caregiver has access to and/or willingness to learn use of a smart phone and the iTCstudy 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 inwriting)

Exclusion

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

Study Design

Total Participants: 31
Treatment Group(s): 1
Primary Treatment: Remote Administration of NSAA
Phase:
Study Start date:
October 02, 2023
Estimated Completion Date:
March 13, 2025

Connect with a study center

  • Red Nucleus Solutions

    Malvern, Pennsylvania 19355
    United States

    Site Not Available

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