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Withdrawn NCT06504667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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06504667). StuddyBuddy aggregates publicly available trial information.