NCT04787640|CompletedResults
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Sponsor study identifier
interventional
3
0 countries
N/A
Study Start
February 20, 2020
Actual (reported)Primary Completion
February 3, 2021
Actual (reported)Study Completion
February 3, 2021
Actual (reported)Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging. They all have similar design features such as a C-shaped spring carbon fiber foot plate that absorbs and returns energy when load is applied deflecting the carbon. In order to accommodate the running pattern which does not show a double stance phase as compared to walking, the Running Specific products do not feature a heel spring but directly load the C-shape spring at initial contact. The Running Specific Feet are usually equipped with additional accessory parts such as a traction sole or spike pad for smoother and more natural rollover. The investigational device, the Nike Sport Sole, is an accessory for the Cheetah Xceed running prosthetic foot. Cheetah Xceed has already been placed on market and bears a CE mark, but the Nike Sport Sole is an upgraded Nike Sole design and the objective of this clinical investigation is to evaluate the observed wear and tear of the soles after 6-8 week usage among other usability aspects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 3, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 20, 2020
Actual (reported)December 29, 2020
Actual (reported)February 3, 2021
Actual (reported)February 3, 2021
Actual (reported)March 8, 2021
Actual (reported)September 4, 2026
Actual (reported)Percentage of Wear and Tear of the Nike Sport Sole
Visual inspection of wear and tear of the Nike Sport Sole using a custom Wear/Tear Scoring Sheet. The Wear/Tear Scoring Sheet is an ordinal rating scale designed to evaluate the physical condition and durability of different regions of the sole-mounted prosthetic product after use. Each item was rated on a 5-point scale (1 = severe wear/damage, 5 = no or minimal wear/damage). Higher scores indicate better product condition and less wear, while lower scores indicate greater wear or damage. Item scores were summed across all assessed regions, divided by the maximum possible total score, and multiplied by 100 to obtain a percentage score. Higher percentages indicate less wear and better overall product condition.
6-8 weeks
The investigational device, the Nike Sport Sole, is an accessory for the Cheetah Xceed running prosthetic foot. Cheetah Xceed has already been placed on market and bears a CE mark, but the Nike Sport Sole is an upgraded Nike Sole design and the objective of this clinical investigation is to evaluate the observed wear and tear of the soles after 6-8 week usage among other usability aspects.
The Nike Sport Sole comes in two different versions, Nike traction sole and Nike spike pad. Both versions are easily attachable and detachable to the foot blade of the running specific prosthetic foot, Cheetah® Xceed. Both sole versions consist of a rubber traction sole with a soft foam core. The Nike spike pad consists of a spike sole with a soft foam core and should be used when running on tartan track. Both sole versions are attached in the same way to the carbon foot blade. The devices slide onto the carbon foot blade and are connected by pulling a strap of the sole over an attachment piece (medallion) that is connected to the foot blade. Additionally, there are attachment clips on the side clamp on the foot blade.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
3 participants (actual enrollment reported by the registry).
First Submitted
December 29, 2020
First Posted
March 8, 2021
Study Start
February 20, 2020
Actual (reported)Primary Completion
Descriptive Study of Receptive Fields in Lower Limb Amputees
Contact the study team to confirm eligibility.
February 3, 2021
Actual (reported)Study Completion
February 3, 2021
Actual (reported)Last Updated
September 4, 2026
Results First Posted
September 4, 2026
Record last verified: 2026-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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