NSAA NON-Interventional Study Protocol

November 20, 2023 updated by: Christopher Jones, PhD, Red Nucleus Enterprise Solutions, LLC

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Malvern, Pennsylvania, United States, 19355
        • Recruiting
        • Red Nucleus Solutions
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with confirmed diagnosis of DMD

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Group A will have Live telemedicine assessments completed prior to caregiver Asynchronous Video
Other: Remote Administration of NSAA
Remote Administration of NSAA
Group B
Group B will have Caregiver Asynchronous Video first, followed by live telemedicine
Other: Remote Administration of NSAA
Remote Administration of NSAA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Red Nucleus Enterprise Solutions, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSAA-RWE-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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