To Assess the Utility of the Point Digit in a Clinical Take-home Study
Completed · Not applicable
Conditions studied: Amputation; Traumatic, Hand
In brief
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.
Key facts
- Study ID
- NCT04755790
- Run by
- Point Designs
- People needed
- 13
- Starts
- 2020-05-18
- Expected to finish
- 2022-12-31
- Last updated by the study team
- 2024-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Point Designs — Lafayette, Colorado, United States
- Arm Dynamics — Overland Park, Kansas, United States
- Arm Dynamics — Maple Grove, Minnesota, United States
- Arm Dynamics — Portland, Oregon, United States
- Arm Dynamics — Philadelphia, Pennsylvania, United States
- Arm Dynamics — Houston, Texas, United States
- Arm Dynamics — Irving, Texas, United States
Full record on ClinicalTrials.gov
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