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Withdrawn
NCT06504667
To Validate Point Mini User Needs
Conditions: Amputation; Traumatic, Hand, Amputation, Congenital
Sex: All
Ages: 5 Years – 15 Years
Healthy volunteers: No
Phase: NA
Sponsor: Point Designs
Location: University of Colorado Denver | Anschutz Medical Campus Aurora Colorado
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06504667). StuddyBuddy aggregates publicly available trial information.