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To Validate Point Mini User Needs
The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.
Conditions:
🦠 Amputation; Traumatic, Hand 🦠 Amputation, Congenital
🗓️ Study Start (Actual) 15 November 2024
🗓️ Primary Completion (Estimated) 15 March 2025
✅ Study Completion (Estimated) 15 March 2025
👥 Enrollment (Estimated) 5
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Aurora, Colorado, United States
📍 Lafayette, Colorado, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Partial hand loss with at least index and/or middle fingers loss at the MCP level
    • * Intact thumb with full range of motion
    • * Fluent in English
    • * Between the ages of 5 and 15 years

    Exclusion Criteria:

    • * Patients with a residual limb that is unhealed from the amputation surgery
    • * Unhealed wounds
    • * Significant cognitive deficits as determined upon clinical evaluation
    • * Significant neurological deficits as determined upon clinical evaluation
    • * Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
    • * Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
    • * Serious uncontrolled medical problems as judged by the project therapist
Ages Eligible for Study: 5 Years to 15 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 10 July 2024
  • First Submitted that Met QC Criteria 10 July 2024
  • First Posted 17 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 July 2024
  • Last Update Posted 22 July 2024
  • Last Verified July 2024
I'm interested ...!!