Innovative Shoe for People With Foot Drop

NCT06911151 | Not Yet Recruiting

• 1 other identifier: NIHR207749
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Foot Drop

Keywords

foot drop; gait; trips and falls; footwear; walking disability

Outcome Measures

Primary Outcomes (1)

• daily use of HDC footwear

  Baseline (t0): Participants are given a paper or electronic diary at baseline, in which they record for each day during the 6 week intervention period how often and how long they used the new footwear (HDC shoe). They will also record any adverse events related to wearing the HDC shoe

  from baseline (t0) , every day to the end of the intervention period at 6 weeks

Secondary Outcomes (15)

• Timed 2 minute walk test

  at baseline (t0)

• Timed 2 minute walk test

  after 6 weeks with the intervention (t1)

• Canadian Occupational Performance Measure

  at baseline (t0)

• Canadian Occupational Performance Measure

  at the end of the intervention period at 6 weeks (t1)

• Weekly step count

  seven days before baseline (t0)

Other Outcomes (1)

• Qualitative Interviews

  At three weeks after the intervention period (t1), at 9 weeks

Study Arms (1)

innovative footwear

EXPERIMENTAL

The Edinburgh-based Health Design Collective (HDC), led by three physiotherapists and one podiatrist and supported by people with lived experience, have designed footwear that incorporates the support needed to reduce foot drop. This footwear includes 'Smartstrap Technology' - integrated elastic straps that help to hold the foot in a good position when walking. The footwear does not require any additional devices and people who have tested it find that the footwear makes their walking easier, while also being usable, comfortable, and unobtrusive.

Device: innovative footwear

Interventions

innovative footwear DEVICE

HDC shoe

innovative footwear

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18+ years
• Individuals experiencing foot drop as diagnosed by a health professional due to any health condition for 6 months or more
• the ability to walk at least 6 metres (with or without walking aid) at their own pace
• with capacity to consent
• Those with English as a 2nd language may bring a translator.

You may not qualify if:

• impaired cognitive function (as assessed in the initial phone call using elements of the Abbreviated Mental Test Score27) and questions that will assess the potential participant's understanding of the research protocol);
• inability to achieve minimum 10 degrees ankle flexion;
• lymphoedema of lower limbs/ deep vein thrombosis in the last 6 months;
• any change in medication/treatment in the last 3 months that may cause a change in walking experience;
• existing pressure areas at risk of, or active skin breakdown in areas that will make contact with the inner of the shoe.

Sponsors & Collaborators

• Queen Margaret University: lead

Study Sites (1)

Queen Margaret University

Edinburgh, Lothian, EH21 6UU, United Kingdom

Location

Related Publications (2)

• Kadaba MP, Ramakrishnan HK, Wootten ME. Measurement of lower extremity kinematics during level walking. J Orthop Res. 1990 May;8(3):383-92. doi: 10.1002/jor.1100080310.

  PMID: 2324857 BACKGROUND

• Bulley C, Shiels J, Wilkie K, Salisbury L. User experiences, preferences and choices relating to functional electrical stimulation and ankle foot orthoses for foot-drop after stroke. Physiotherapy. 2011 Sep;97(3):226-33. doi: 10.1016/j.physio.2010.11.001. Epub 2011 Feb 2.

  PMID: 21820541 BACKGROUND

MeSH Terms

Conditions

Peroneal Neuropathies; Mobility Limitation

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vicki Cameron, BSc, PhD

CONTACT

+447846087592; vcameron@qmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: pre- post single group design

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 4, 2025
• Study Start: June 20, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

GB (1)