Status:
COMPLETED
To Assess the Utility of the Point Digit in a Clinical Take-home Study
Lead Sponsor:
Point Designs
Collaborating Sponsors:
University of Colorado, Denver
Arm Dynamics
Conditions:
Amputation; Traumatic, Hand
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 D...
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 :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04755790
Start Date
May 18 2020
End Date
December 31 2022
Last Update
January 24 2024
Active Locations (7)
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1
Point Designs
Lafayette, Colorado, United States, 80026
2
Arm Dynamics
Overland Park, Kansas, United States, 66209
3
Arm Dynamics
Maple Grove, Minnesota, United States, 55369
4
Arm Dynamics
Portland, Oregon, United States, 97223