Clinical Research Directory

Innovative Shoe for People With Foot Drop

Sponsor: Queen Margaret University

Summary

People with foot drop have an increased risk of tripping and falling, and this makes walking more difficult. Our colleagues at the Health Design Collective (HDC) have developed a shoe that aims to make it easier for people with foot drop to walk. People who have tested a prototype of the shoe, have told us that it makes their walking easier, but is also comfortable and unobtrusive. However, the investigators need more scientific evidence that this shoe helps reduce foot drop and improves walking in people with foot drop. The purpose of this small study, with only 15 participants, is to lay the foundations to design and carry out a bigger study. participants have been asked to take part if they are aged 18+ years and have experienced foot drop in the past 6 months or more. To be able to take part in this study participants need to be able to walk for 2 minutes without stopping (with or without their normal walking aid) and have sufficient movement in their ankle to use the shoe. Unfortunately, if the participant has severe swelling of their legs, deep vein thrombosis, or severe problems with the skin on their feet, they will not be able to take part in this study. If the participant agrees to take part, they will be fitted with a pair of the new shoes and asked to try them out for a period of 6 weeks. They will continue to wear any orthotics/ankle foot orthotics or other aids that they are currently using. Before and during these six weeks the investigators will ask the participant to wear a small device that measures their physical activity. Just before and after these 6 weeks the investigators will invite the participant to Queen Margaret University for some walking tests with the new shoes. The investigators will also ask the participant to complete several questionnaires which they can do at home. After the 6-week shoe testing period the investigators will invite the participant for an interview, either in person or remotely, during which they can tell the researchers their thoughts about the new shoe. Participants will be asked to travel to Queen Margaret University, Musselburgh and all of their travel expenses to and from the university will be reimbursed. The study involves testing a new shoe which participants might find uncomfortable and take some time to get used to. The investigators will support participants throughout 6 weeks testing period to make sure that they are safe and free of pain when using the shoes. If participants experience any issues related to the shoes, they should stop wearing them and contact the investigators. The two study assessments will involve several walking tests that participants may find tiring. People who have tested an early prototype of the shoe, have told the research team that it makes their walking easier, but is also comfortable and unobtrusive. However, it is possible participants will not experience these benefits. The investigators hope this study also helps people in the future to find out more about how this research can develop the shoes and how it impacts people affected by foot drop. If participants find them useful, they can keep the shoes after taking part in the study. If they are interested in taking part in this study after reading this information sheet, please contact the researcher to discuss the study and ask any questions. If participants decide to take part, they will be asked to complete a paper or electronic consent form. If they are happy to sign the consent form, the research team will send them a short survey with a couple of questions such as their age, shoe size, health condition, and how long they have experienced foot drop. This will allow the research team to order shoes in the correct size for the participant. Once the study period starts, the participant will record any falls they have had over a period of 6 weeks in either a paper or electronic diary, whichever they prefer. It is valuable for the General Practitioner (GP), orthotist and podiatrist, to know who is taking part in research. If the participant has given the investigators consent to do so, the research team will inform the participants GP, orthotist and podiatrist that the participant is taking part in the study. In addition, the participant will be sent a small, lightweight activity monitor (picture below) and asked to wear it by attaching it to their leg for a period of 7 days. This monitor records how many steps that are taken each day and how fast the person is walking. The participant will be asked to wear the monitor whilst sleeping, if possible, but they will need to remove it for bathing and swimming. After a period of about 6 weeks, the investigators will invite the participant to Queen Margaret University, Musselburgh to fit them with a pair of HDC shoes. If English is the 2nd language, the person may bring a translator if they wish. Any travel expenses to and from the University will be reimbursed.

Official title: Innovative Footwear for People Experiencing Foot Drop; a Feasibility Study

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