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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1
University of Colorado Denver | Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Point Designs
Lafayette, Colorado, United States, 80026