Status:

COMPLETED

Validation of User Needs of the Point Digit With Partial Hand Amputees

Lead Sponsor:

Point Designs

Collaborating Sponsors:

University of Colorado, Denver

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions:

Amputation; Traumatic, Hand

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amput...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 7 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 30 2022

Estimated Enrollment :

7 Patients enrolled

Trial Details

Trial ID

NCT04763278

Start Date

January 7 2021

End Date

March 30 2022

Last Update

September 27 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of Colorado Denver | Anschutz Medical Campus

Aurora, Colorado, United States, 80045

2

Point Designs

Lafayette, Colorado, United States, 80026