NCT06054971Completed
NSAA NON-Interventional Study Protocol
Use of Telemedicine and At-Home Video for Remote Administration of the North Star Ambulatory Assessment (NSAA): a Feasibility Study
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 31 (actual)
- First submitted
- 12 Sept 2023
- Start date
- Oct 2023
- Primary completion date
- Feb 2025
- Lead sponsor
- Red Nucleus Enterprise Solutions, LLC
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT06054971
What you commit to
- Study type: Observational
- Participants enrolled: 31
- From Oct 2023 to the primary completion date, Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 4 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Red Nucleus Solutions Coordinator of this site? Confirm its status | Malvern | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.