Foot DropNCT06115161
Development and Validation of an Instrumented Ankle-foot Orthosis
A study testing Instrumented Orthosis in people with Foot Drop, run by TOPMED at 1 site in Canada.
Trial summary
Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Foot Drop
- What is being tested?
- Instrumented Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 13 Sep 2023to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having foot drop
- Being a clinician who treats foot drop patients
- Having foot drop
Who cannot join
- Not being able to walk without a cane or a walker
- Having lower extremity spasticity
Trial locations and contacts
1 site in 1 country.
About this study
Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling.
TurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort.
- Conditions
- Foot Drop
- Being tested
- Instrumented Orthosis
- Keywords
- ankle foot orthosis, validation, survey, gait analysis, biomecanics
- Medical subject headings
- Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented OrthosisDevice
Gait analysis will be performed with the instrumented orthosis as well as the reference system.
| Study group | Role | What they receive |
|---|---|---|
| Gait Analysis | Experimental | Gait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5). Receives: Device: Instrumented Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Temporal parameters
Gait Temporal parameters measured by the instrumented orthosis and the reference system, in seconds, these include the different phase durations(stride, stance and swing).
Measured: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Heel strike angle
Heel strike angle measured by the instrumented orthosis and the reference system
Measured: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait Spatial parameters
Gait Spatial parameters measured by the instrumented orthosis and the reference system, in meters, these include the length and width of the stride.
Measured: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait speed
Gait speed measured by the instrumented orthosis and the reference system, in meters per second.
Measured: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start13 Sep 2023
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Why it stopped: The instrumented orthosis prototype was never finished.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Trial with condition crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TOPMED
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Turbomed Orthotics Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115161
- Sponsor's protocol ID
- 241_Tur_ApEval
- Status last verified
- Mar 2025
- First submitted
- 13 Sep 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Instrumented Ankle-foot Orthosis
- ClinicalTrials.gov ID
- NCT06115161
- Acronym / sponsor ID
- 241_Tur_ApEval
- Conditions
- Foot Drop
- Keywords
- ankle foot orthosis, validation, survey, gait analysis, biomecanics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The instrumented orthosis prototype was never finished.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TOPMEDUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Turbomed Orthotics Inc.
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 2 Nov 2023 (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.
Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling.
TurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Trial with condition crossover
| Arm | Type | Receives |
|---|---|---|
| Gait Analysis | Experimental | Device: Instrumented OrthosisGait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having foot drop
- Being a clinician who treats foot drop patients
- Having foot drop
Key exclusion criteria (2 listed)
- Not being able to walk without a cane or a walker
- Having lower extremity spasticity
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 |
|---|---|---|
| Instrumented OrthosisGait analysis will be performed with the instrumented orthosis as well as the reference system. | Device | Gait Analysis |
Primary outcome
Gait Temporal parameters
Time frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait Temporal parameters measured by the instrumented orthosis and the reference system, in seconds, these include the different phase durations(stride, stance and swing).
Heel strike angle
Time frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Heel strike angle measured by the instrumented orthosis and the reference system
Gait Spatial parameters
Time frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait Spatial parameters measured by the instrumented orthosis and the reference system, in meters, these include the length and width of the stride.
Gait speed
Time frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait speed measured by the instrumented orthosis and the reference system, in meters per second.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrumented Orthosis in people with Foot Drop, run by TOPMED at 1 site in Canada.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 20 Mar 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Temporal parameters (time frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.