Status:
NOT_YET_RECRUITING
To Evaluate the Clinical Impact of the Point Powered System
Lead Sponsor:
Point Designs
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Hanger Clinic: Prosthetics & Orthotics
Conditions:
Amputation; Traumatic, Hand
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the efficacy of the Point Powered system as compared to the patient's standard-of-care treatment. This study will be a single subject crossover design where ...
Eligibility Criteria
Inclusion
- Partial unilateral hand loss with at least index and/or middle fingers amputated at the MCP level
- Intact thumb with full range of motion
- Fluent in English
- Age of 18 years or older
Exclusion
- Patients with a residual limb that is unhealed from the amputation surgery
- Unhealed wounds
- 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 clinical evaluation
- Serious uncontrolled medical problems as judged by the project therapist
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07135947
Start Date
November 1 2025
End Date
August 31 2026
Last Update
August 22 2025
Active Locations (3)
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1
University of Colorado Denver | Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Point Designs
Broomfield, Colorado, United States, 80020
3
Hanger Clinic
Lafayette, Colorado, United States, 80026