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.
