The Influence of 3D Printed Prostheses on Neural Activation Patterns

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 3 years 11 months later Aug 2026 → Aug 2030
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Record History

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  1. Primary and study completion pushed from Aug 2026 to Aug 2030
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Aug 2025 to Aug 2026v10
  3. Re-verified, no change to tracked fieldsv9
  4. Primary and study completion dates: Aug 31, 2025 to Aug 2025v8
  5. Primary completion date: Aug 31, 2023 to Aug 31, 2025
    • Study completion date: Aug 31, 2024 to Aug 31, 2025
    • Site contact updated
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. 2 versions Re-verified since Nov 4, 2022, no change to tracked fieldsv5-v6
  2. Phase: Not specified to Not applicable
    • Study completion date: Aug 31, 2023 to Aug 31, 2024
    • Eligibility criteria revised
    • Study description revised
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2020 to Jan 10, 2020
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The neural basis underlying motor performance in children using a prosthesis has been severely understudied resulting in minimal empirical evidence. The use of functional near-infrared spectroscopy (fNIRS) in conjunction with customized and visually appealing 3D printed prostheses would provide the unique opportunity to quantitatively assess the influence of upper-limb prostheses in the neural activation patterns of the primary motor cortex and motor performance of children. This information would increase the investigators limited knowledge of how prosthesis usage influences the primary motor cortex of growing children and use this information to develop rehabilitation programs aimed at reducing prosthesis rejection and abandonment.
Trial Details
NCT Number NCT04110730
Lead Sponsor University of Nebraska
Conditions
(from sponsor)		 Amniotic Band Syndrome, Upper Extremity Deformities, Congenital
Related terms Amniotic Band Syndrome, Upper Extremity Deformities, Congenital
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov