To Assess the Utility of the Point Mini in a Clinical Take-home Study
NCT ID: NCT06501092
Last Updated: 2025-06-24
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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RECRUITING
NA
14 participants
INTERVENTIONAL
2025-06-18
2026-07-31
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
CROSSOVER
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 Mini
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
Point Mini
Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
Interventions
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Point Mini
Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
Eligibility Criteria
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Inclusion Criteria
* Intact thumb with full range of motion
* Fluent in English
* Age between 5 and 15 years
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
5 Years
15 Years
ALL
No
Sponsors
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Children's Healthcare of Atlanta
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
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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Point Designs
Lafayette, Colorado, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 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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445970
Identifier Type: -
Identifier Source: org_study_id
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