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NCT05990062 · ClinicalTrials.gov registry record · NA
Improving Prosthetic Arms for Amputee: A Better Fit and More Functionality
A NA study of Amputation, Surgical, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05990062 is a NA study of Amputation, Surgical that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 25 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05990062, a NA study of Amputation, Surgical, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This research and development will improve upon and investigate the potential validity of an innovative new transradial socket and harness design (the KSH system) that offers an alternative to standard hard sockets and rubber liners with a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The project consists of designing, custom fitting and evaluating the function and comfort of the this new novel system. The study will take place in 3 phases; Phase 1, five experienced Veterans with transradial arm amputations will be recruited to provide guidance and to assist with the design and development. Experienced end-user Veterans and Clinical staff will work together to assist with design, develop the fitting process and working with engineers on the design of a completely digital fitting device for measuring the residual limb and locating bony prominences of the limb to inform the socket design. Phase 2, testing and assessment, the design and process validation will take place with the five Veteran upper transradial arm amputees Phase 3, an additional 20 Veterans with transradial arm amputations will be recruited and fit with the KSH system and undergo a series of evaluative tests. Veterans will perform a series of static and dynamic tasks to evaluate function, comfort and load bearing failure. The primary goal of this study is to improve upon the current preliminary prototype and to test it with a broader population of potential users to help advance the engineering and design, and to learn the potential to fit a range of Veterans with transradial amputations.
Conditions Studied
Interventions
- DEVICE K-Socket-Harness
Study Locations (1)
Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-06-01 |
| Est. Completion | 2028-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05990062
The ClinicalTrials.gov registry entry for NCT05990062 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amputation, Surgical appearing as the primary indexed condition, and to 1 intervention - of which K-Socket-Harness is the first listed.
NCT05990062 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05990062 about?
NCT05990062 is a clinical study titled "Improving Prosthetic Arms for Amputee: A Better Fit and More Functionality". This research and development will improve upon and investigate the potential validity of an innovative new transradial socket and harness design (the KSH system) that offers an alternative to standard hard sockets and rubber liners with a hybrid polymer and textile-based design derived from advance...
What is the current status of trial NCT05990062?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2025-06-01. Estimated completion is 2028-09-30.
What conditions does trial NCT05990062 study?
This clinical trial studies the following conditions: Amputation, Surgical.
What interventions are being tested in trial NCT05990062?
The interventions under investigation include: K-Socket-Harness (DEVICE).
Who is sponsoring clinical trial NCT05990062?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05990062 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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