Trial Outcomes & Findings for Wear and Tear Evaluation of New Nike Sport Sole for Runnnig Prosthesis (NCT NCT04787640)
NCT ID: NCT04787640
Last Updated: 2026-09-04
Results Overview
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.
COMPLETED
3 participants
6-8 weeks
2026-09-04
Participant Flow
Participant milestones
| Measure |
Wear and Tear of New Nike Sport Sole
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.
Nike Sport Sole: 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.
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Overall Study
STARTED
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3
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Overall Study
COMPLETED
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2
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Wear and Tear of New Nike Sport Sole
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.
Nike Sport Sole: 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.
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Wear and Tear of New Nike Sport Sole
n=3 Participants
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.
Nike Sport Sole: 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.
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Age, Customized
Mean age (SD)
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42 years
STANDARD_DEVIATION 10.4 • n=3 Participants
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Sex: Female, Male
Female
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0 Participants
n=3 Participants
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Sex: Female, Male
Male
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3 Participants
n=3 Participants
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Region of Enrollment
United States
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3 Participants
n=3 Participants
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PRIMARY outcome
Timeframe: 6-8 weeksVisual 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.
Outcome measures
| Measure |
Wear and Tear of New Nike Sport Sole
n=2 Participants
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.
Nike Sport Sole: 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.
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Percentage of Wear and Tear of the Nike Sport Sole
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75 percentage of total score
Standard Deviation 0
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Adverse Events
Wear and Tear of New Nike Sport Sole
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical evaluation and investigation specialist
Össur Iceland ehf.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place