Foot DropNCT06911151
Innovative Shoe for People With Foot Drop
A study testing innovative footwear in people with Foot Drop, run by Queen Margaret University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Drop
- What is being tested?
- innovative footwear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Queen Margaret University
Edinburgh, Lothian, EH21 6UU
Marietta van der linden, MSc, PhD, 0131 474 0000, mvanderlinden@qmu.ac.uk
Cathy Bulley, PhD, 0131 474 0000, cbulley@qmu.ac.uk
About this study
Official title: Innovative Footwear for People Experiencing Foot Drop; a Feasibility Study
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.
Read the detailed description
The investigators will ask the participant to carry out two different types of walking tests. Both tests will be repeated twice: 1) with new shoes but with no tension (standard shoes) 2) with the new shoes applying tension using a special strap which is designed to reduce foot drop. participants are allowed to rest between each test for as long as they need and may use their usual walking aids. The first test involves walking around two cones about 10 meters apart for a maximum of 2 minutes without stopping.
For the second type of walking test, the investigators will need to attach small reflective balls (markers) to their legs and pelvis using skin-friendly sticky tape (see picture below). Using special cameras that only see the reflective markers, the researchers can create a very detailed and accurate measurement of how their legs move when they walk. For this walking test, researchers will ask participants to walk about 6 meters, six times: three times using the shoes with no tension, and three times in the shoes with the tension applied to the affected foot. Participants can walk at a speed that is comfortable to them and can stop and rest whenever they wish. Investigators will ask participants to complete two questionnaires, one about how their health condition affects their quality of life, and the other one about which clinical services (e.g. GP, physiotherapy) they have used in the past 6 weeks. participants can complete these at home before their visit or after the walking tests, either in paper or electronic format, whichever they prefer. It should take no more than half an hour to complete these questionnaires.
Investigators will also ask participants to rate their our ability to carry out up to five daily activities that are important to them (e.g., walking upstairs, shopping, doing housework), on a scale of 1 (can't do it activity) to 10 (I have no problem at all doing this activity).
After the first visit
Researchers will ask participants to use the new shoe with the special strap at home for a duration of 6 weeks. During the first week, they will be asked to follow a safety and footwear adaptation protocol which will help them get used to the shoes. For the following five weeks, they are free to use the shoes whenever they wish. During the 6 weeks between visits, investigators will ask participants to complete an electronic or paper diary recording their use of the shoes and any specific challenges/feedback and whether they had a fall. If participants have any questions or need any help to complete the diary or with wearing the shoes, they can contact the researcher at any point.
A week before the second scheduled visit, researchers will ask participants to wear the activity monitor on their leg again for a period of 7 days. The process for the second visit will be the same as the first visit, except for a short additional footwear survey to find out the opinions about the shoes. Interviews will be conducted in person or remotely, depending on the preference. The remote interviews will be carried out online or by telephone. All interviews will be recorded using a digitally encrypted audio recorder. Interviews will be carried out to find out the views and perspectives relating to the use of the new shoes. participants will be asked about their positive and negative experiences or impacts and thoughts on the ongoing use of new shoes. It is not thought that there are any disadvantages; however, it is important that participants are careful when they start to use the new shoes. They will need to become accustomed to the shoe, which may take up to 1 week. Investigators will support participants and help by giving a safety protocol to follow. If there are any concerns at any time, people are advised to immediately stop wearing the shoes and contact the researcher to discuss. The researcher's contact details are provided in the diary, please also record all safety concerns in the diary. Key areas of safety concerns are as follows:
When wearing the shoe, has the participant had any falls or near falls?
When the participant wears the shoe, do they experience any pain?
After wearing the shoe, do they notice any areas of skin redness or skin breakdown?
As previously explained, people can withdraw from the study at any point, without having to give a reason.
At the end of the study, people can keep the pair of new shoes at no cost if they have found them useful. If participants would like to receive a lay summary of the study findings, researchers can send this once they have finished analysing the data.
- Conditions
- Foot Drop
- Being tested
- innovative footwear
- Keywords
- foot drop, gait, trips and falls, footwear, walking disability
- Medical subject headings
- Peroneal Neuropathies, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
innovative footwearDevice
HDC shoe
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: innovative footwear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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): walking will be assessed through the 2 minute walking test at baseline (t0) . Participants will be asked to walk up and down the motion analysis laboratory around 2 cones, placed 10 metres apart, for a duration of 2 minutes. They will be instructed to cover as much distance as possible in a safe manner within a two minute duration without stopping to rest. Participants will be allowed to use their normal walking aids.
Measured: at baseline (t0)
Timed 2 minute walk test
After 6 weeks with the intervention (t1) walking will be assessed through the 2 minute walking test. Participants will be asked to walk up and down the motion analysis laboratory around 2 cones, placed 10 metres apart, for a duration of 2 minutes. They will be instructed to cover as much distance as possible in a safe manner within a two minute duration without stopping to rest. Participants will be allowed to use their normal walking aids.
Measured: after 6 weeks with the intervention (t1)
Canadian Occupational Performance Measure
At baseline (t0) participants will complete the COPM wh9ch is a semi-structured interview, ratings from 1 to 10, higher scores indicate higher perceived improvement in function
Measured: at baseline (t0)
Canadian Occupational Performance Measure
At the end of the intervention period at 6 weeks (t1) participants will complete the COPM which is a semi-structured interview, ratings from 1 to 10, higher scores indicate higher perceived improvement in function
Measured: at the end of the intervention period at 6 weeks (t1)
Weekly step count
Participants will wear the activity monitor for the seven days before baseline, measured using an ActivPal activity monitor
Measured: seven days before baseline (t0)
Weekly step count
Participants will wear the activity monitor for seven days measured using an ActivPal activity monitor
Measured: at week 5, which is one week before the end of the 6 week intervention period (t1)
Gait analysis
At baseline (t0) Gait analysis with the vicon motion analysis. Computerised three domensional gait analysis will be used to measure lower limb kinematics, and specifically joint angles between the foot and the lower limb segment to measure dorsiflexion movement in the sagittal plane.
Measured: baseline (t0)
Gait analysis
After the 6 week intervention period at 6 weeks (t1), Gait analysis with the vicon motion analysis. Computerised three domensional gait analysis will be used to measure lower limb kinematics, and specifically joint angles between the foot and the lower limb segment to measure dorsiflexion movement in the sagittal plane.
Measured: after the 6 week intervention period, at 6 weeks (t1)
Falls
For 6 weeks prior to baseline (t0), The participants will be asked to record any trips and / or falls that they have in a falls diary.
Measured: starting at day 1, for 6 weeks prior to baseline (t0)
Falls
During the 6 week intervention period, from baseline (t0) until the end of the 6 week intervention period at 6 weeks (t1),The participants will be asked to record any trips and / or falls that they have in a falls diary.
Measured: from baseline (t0) until the end of the intervention period at 6 weeks (t1)
Euro-Qol EQ-5D
At baseline (t0), Quality of life survey
Measured: baseline (t0)
Euro-Qol EQ-5D
After the 6 week intervention period at 6 weeks (t1), Quality of life survey
Measured: After the 6 week intervention period at 6 weeks (t1)
Footwear Survey
After the 6 week intervention period at 6 weeks (t1), A survey to determine the participants thoughts and opinions on the footwear
Measured: After the 6 week intervention period at 6 weeks (t1)
Health evaluation survey
At baseline (t0), Health evaluation survey to determine the financial implications of the burden of foot drop
Measured: baseline (t0)
Health evaluation survey
At the end of the 6 week intervention period at 6 weeks (t1), Health evaluation survey to determine the financial implications of the burden of foot drop
Measured: at the end of the 6 week intervention period at 6 weeks (t1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start20 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Foot DropStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre- post single group design
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marietta van der Linden, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911151
- Sponsor's protocol ID
- NIHR207749
- Other IDs
- NIHR207749
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonymous data may be shared on request from other researchers
Publications
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.
PubMed 2324857Bulley 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.
PubMed 21820541
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Footwear for People Experiencing Foot Drop; a Feasibility Study
- ClinicalTrials.gov ID
- NCT06911151
- Acronym / sponsor ID
- NIHR207749
- Conditions
- Foot Drop
- Keywords
- foot drop, gait, trips and falls, footwear, walking disability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will ask the participant to carry out two different types of walking tests. Both tests will be repeated twice: 1) with new shoes but with no tension (standard shoes) 2) with the new shoes applying tension using a special strap which is designed to reduce foot drop. participants are allowed to rest between each test for as long as they need and may use their usual walking aids. The first test involves walking around two cones about 10 meters apart for a maximum of 2 minutes without stopping.
For the second type of walking test, the investigators will need to attach small reflective balls (markers) to their legs and pelvis using skin-friendly sticky tape (see picture below). Using special cameras that only see the reflective markers, the researchers can create a very detailed and accurate measurement of how their legs move when they walk. For this walking test, researchers will ask participants to walk about 6 meters, six times: three times using the shoes with no tension, and three times in the shoes with the tension applied to the affected foot. Participants can walk at a speed that is comfortable to them and can stop and rest whenever they wish. Investigators will ask participants to complete two questionnaires, one about how their health condition affects their quality of life, and the other one about which clinical services (e.g. GP, physiotherapy) they have used in the past 6 weeks. participants can complete these at home before their visit or after the walking tests, either in paper or electronic format, whichever they prefer. It should take no more than half an hour to complete these questionnaires.
Investigators will also ask participants to rate their our ability to carry out up to five daily activities that are important to them (e.g., walking upstairs, shopping, doing housework), on a scale of 1 (can't do it activity) to 10 (I have no problem at all doing this activity).
After the first visit
Researchers will ask participants to use the new shoe with the special strap at home for a duration of 6 weeks. During the first week, they will be asked to follow a safety and footwear adaptation protocol which will help them get used to the shoes. For the following five weeks, they are free to use the shoes whenever they wish. During the 6 weeks between visits, investigators will ask participants to complete an electronic or paper diary recording their use of the shoes and any specific challenges/feedback and whether they had a fall. If participants have any questions or need any help to complete the diary or with wearing the shoes, they can contact the researcher at any point.
A week before the second scheduled visit, researchers will ask participants to wear the activity monitor on their leg again for a period of 7 days. The process for the second visit will be the same as the first visit, except for a short additional footwear survey to find out the opinions about the shoes. Interviews will be conducted in person or remotely, depending on the preference. The remote interviews will be carried out online or by telephone. All interviews will be recorded using a digitally encrypted audio recorder. Interviews will be carried out to find out the views and perspectives relating to the use of the new shoes. participants will be asked about their positive and negative experiences or impacts and thoughts on the ongoing use of new shoes. It is not thought that there are any disadvantages; however, it is important that participants are careful when they start to use the new shoes. They will need to become accustomed to the shoe, which may take up to 1 week. Investigators will support participants and help by giving a safety protocol to follow. If there are any concerns at any time, people are advised to immediately stop wearing the shoes and contact the researcher to discuss. The researcher's contact details are provided in the diary, please also record all safety concerns in the diary. Key areas of safety concerns are as follows:
When wearing the shoe, has the participant had any falls or near falls?
When the participant wears the shoe, do they experience any pain?
After wearing the shoe, do they notice any areas of skin redness or skin breakdown?
As previously explained, people can withdraw from the study at any point, without having to give a reason.
At the end of the study, people can keep the pair of new shoes at no cost if they have found them useful. If participants would like to receive a lay summary of the study findings, researchers can send this once they have finished analysing the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre- post single group design
| Arm | Type | Receives |
|---|---|---|
| innovative footwear | Experimental | Device: innovative footwearThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| innovative footwearHDC shoe | Device | innovative footwear |
Primary outcome
daily use of HDC footwear
Time frame: from baseline (t0) , every day to the end of the intervention period at 6 weeks
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
15 secondary outcomes
Timed 2 minute walk test
Time frame: at baseline (t0)
Timed 2 minute walk test
Time frame: after 6 weeks with the intervention (t1)
Canadian Occupational Performance Measure
Time frame: at baseline (t0)
Canadian Occupational Performance Measure
Time frame: at the end of the intervention period at 6 weeks (t1)
Weekly step count
Time frame: seven days before baseline (t0)
Weekly step count
Time frame: at week 5, which is one week before the end of the 6 week intervention period (t1)
Gait analysis
Time frame: baseline (t0)
Gait analysis
Time frame: after the 6 week intervention period, at 6 weeks (t1)
Falls
Time frame: starting at day 1, for 6 weeks prior to baseline (t0)
Falls
Time frame: from baseline (t0) until the end of the intervention period at 6 weeks (t1)
Euro-Qol EQ-5D
Time frame: baseline (t0)
Euro-Qol EQ-5D
Time frame: After the 6 week intervention period at 6 weeks (t1)
Footwear Survey
Time frame: After the 6 week intervention period at 6 weeks (t1)
Health evaluation survey
Time frame: baseline (t0)
Health evaluation survey
Time frame: at the end of the 6 week intervention period at 6 weeks (t1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 2324857Kadaba 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.
- Background: PubMed 21820541Bulley 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.
- Individual participant dataSharing planned: Undecided. anonymous data may be shared on request from other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing innovative footwear in people with Foot Drop, run by Queen Margaret University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vicki Cameron, BSc, PhD (+447846087592, vcameron@qmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily use of HDC footwear (time frame: from baseline (t0) , every day to the end of the intervention period at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06911151, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.