To Evaluate the Clinical Impact of the Point Powered System
NCT ID: NCT07135947
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2025-11-01
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Current/No Device
Baseline outcome measurements will be performed with subject's existing partial hand prosthetic treatment, as deemed standard-of-care by the patient's prosthetist. Device types include, but are not limited to, no prosthesis, passive prosthesis, passive positional prosthesis, body-powered prosthesis, myoelectric prosthesis, or other assistive device.
No interventions assigned to this group
Point Powered
Outcome measurements will be performed after the subject has been fit with the Point Powered at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
Point Powered partial hand prosthetic system
The Point Powered system includes 1-4 3-joint mechatronic digits, low-profile EMG electrodes, a low-profile controller, and flexible batteries. These components will be integrated into a waterproof and dustproof packaging
Interventions
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Point Powered partial hand prosthetic system
The Point Powered system includes 1-4 3-joint mechatronic digits, low-profile EMG electrodes, a low-profile controller, and flexible batteries. These components will be integrated into a waterproof and dustproof packaging
Eligibility Criteria
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Inclusion Criteria
* Intact thumb with full range of motion
* Fluent in English
* Age of 18 years or older
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Hanger Clinic: Prosthetics & Orthotics
OTHER
University of Colorado, Denver
OTHER
Infinite Biomedical Technologies
INDUSTRY
Point Designs
INDUSTRY
Responsible Party
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Principal Investigators
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Levin Sliker, PhD
Role: PRINCIPAL_INVESTIGATOR
Point Designs
Locations
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University of Colorado Denver | Anschutz Medical Campus
Aurora, Colorado, United States
Point Designs
Broomfield, Colorado, United States
Hanger Clinic
Lafayette, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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348027
Identifier Type: -
Identifier Source: org_study_id
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