Lafayette, Colorado 80026

  • Amputation; Traumatic, Hand

Purpose:

This study will allow us to assess whether the Point Digit confers functional and psychological benefit to persons with partial hand amputations in an unconstrained environment. The use of the Point Digit outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.


Criteria:

Inclusion Criteria: - Partial hand amputees with absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met. - Fluent in English - Individuals aged 18 or greater Exclusion Criteria: - 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 occupational therapist evaluation - Serious uncontrolled medical problems as judged by the project therapist.


NCT ID:

NCT04755790


Primary Contact:

Levin Sliker, PhD
Phone: 7206004753
Email: levin@pointdesignsllc.com


Backup Contact:

N/A


Location Contact:

Lafayette, Colorado 80026
United States

Levin Sliker, PhD
Phone: 720-600-4753
Email: levin@pointdesignsllc.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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