Duchenne Muscular Dystrophy Clinical Trial
Official title:
Use of Telemedicine and At-Home Video for Remote Administration of the North Star Ambulatory Assessment (NSAA): A Feasibility Study
| NCT number | NCT06054971 |
| Other study ID # | NSAA-RWE-001 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2, 2023 |
| Est. completion date | May 2024 |
| Verified date | November 2023 |
| Source | Red Nucleus Enterprise Solutions, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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 | Recruiting |
| Enrollment | 30 |
| Est. completion date | May 2024 |
| Est. primary completion date | May 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 4 Years to 12 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Red Nucleus Solutions | Malvern | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Red Nucleus Enterprise Solutions, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 6 Months |
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