Lower Limb Amputation Below Knee (Injury)
Conditions
Keywords
prosthesis, running, nike sole, cheetah
Brief summary
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.
Detailed description
The primary objective of this study is to evaluate the observed wear and tear of the new Nike Sport Sole after 6-8 weeks usage among other usability aspects compared to subjects current prescribed running prosthesis/sole combination. i) Recruitment Potential subjects will be identified from the customer base of the Local Principal Investigator (LPI). LPI evaluates, based on previous experience of interaction with and servicing of patients, if a potential participant is cognitively capable. If a potential participant fits the inclusion and exclusion criteria the LPI will contact them via telephone. During the telephone call the LPI will verify if they are interested in participating in a study. If interest is expressed at this point, they will answer some screening questions and if the eligibility criteria are met an appointment will be made for the clinical visit and signing of the ICF. Questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered. Potential risk of participating in the investigation will be explained to the subject at this point to the candidate for enrolment. The LPI will communicate to the study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate. ii) Test procedure There are two scheduled study events. At the initial visit, the first study event, for each subject a researcher qualified to obtain informed consent will seat the subject and proceed as described in chapter 13.8 Informed consent. Visit 1. Prior to fitting the investigational device, the subjects will be asked to provide feedback on their current prescribed running prosthesis, by filling in a set of questionnaires, run outside, both on level and rolling terrain and attach and detach the sole to blade. Investigators will record name and category of their current device and type of sole used. Picture will be taken of the current device from side and front. The users will then be fitted to the investigational device within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain. Subjects will be asked to provide feedback on the investigational device by filling in same sets of questionnaires and perform the same tasks. Users will be handed a journal to fill out information regarding their sport activities during the next 6-8 weeks while using the investigational device. Visit 2. The second event will take place 6-8 weeks later. When the subjects arrive at the clinic, investigators will take pictures of the investigational device (and IDs) from side and front, review subjects journal and the wear and tear of the investigational device will be evaluated. Alignment will also be reviewed. Subjects will be asked to once again, fill in the same sets of questionnaires as during the first visit and perform the same set of tasks. At last, subjects will be re-fitted to their previous prescribed device, same tasks and questionnaires will once again be repeated.
Interventions
DEVICENike 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.
Sponsors
Össur Iceland ehf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 50Kg\< body weight \< 116Kg * K-level: K3 and K4 * Amputation level: Unilateral, bilateral, Trans-tibial, trans-femoral * Currently using running prosthesis with the option to connect to the components the investigational device is compatible to * Minimum build height: Distance from ground to socket adapter needs to be 318 mm or more. * Comfortable and stable socket fit * Willing and able to participate in the study and follow the protocol
Exclusion criteria
* 50Kg\> body weight \> 116Kg * Users with socket problems * Users with cognitive impairment * Younger than 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Wear and Tear of the Nike Sport Sole | 6-8 weeks | 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. |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Mean age (SD) | 42 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
None listed