Foot DropNCT05163782
Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop
A study testing New ankle foot orthosis with anterior support, Ankle foot orthosis with anterior support and Ankle foot orthosis from competitor 1 in people with Foot Drop, run by TOPMED at 1 site in Canada.
Trial summary
The objective of this research is to compare the new ankle foot orthosis (AFO) with prior support developed by Turbomed, with the AFO with posterior support from Turbomed as well as two competing AFOs currently on the market. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foot Drop
- What is being tested?
- New ankle foot orthosis with anterior support, Ankle foot orthosis with anterior support and Ankle foot orthosis from competitor 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jul 2021to 28 Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Foot drop following surgery or an accident (functional calf, without contracture and not spastic)
- Foot drop following a Cerebral Vascular Accident (with or without spasticity, mild to moderate)
- Ability to stand and walk alone without technical assistance
- Ability to communicate comfort/discomfort
Who cannot join
- Sore to one of the feet
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this research is to compare the new ankle foot orthosis (AFO) with prior support developed by Turbomed, with the AFO with posterior support from Turbomed as well as two competing AFOs currently on the market.
With this research, we seek to answer the following questions:
- Is the new AFO as biomechanically efficient as the AFOs currently on the market?
- Is the new AFO more comfortable than the AFO currently on the market?
- Is the new AFO easier to put on and attach than the AFOs currently on the market?
- Conditions
- Foot Drop
- Being tested
- New ankle foot orthosis with anterior support, Ankle foot orthosis with anterior support, Ankle foot orthosis from competitor 1, Ankle foot orthosis from competitor 2
- Medical subject headings
- Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New ankle foot orthosis with anterior supportDevice
New ankle foot orthosis with anterior support developed by Turbomed
Ankle foot orthosis with anterior supportDevice
Ankle foot orthosis with anterior support from Turbomed
Ankle foot orthosis from competitor 1Device
Ankle foot orthosis with posterior support from competitor 1
Ankle foot orthosis from competitor 2Device
Ankle foot orthosis with posterior support from competitor 2
| Study group | Role | What they receive |
|---|---|---|
| People with foot drop | Experimental | People with left or right foot drop Receives: Device: New ankle foot orthosis with anterior support; Device: Ankle foot orthosis with anterior support; Device: Ankle foot orthosis from competitor 1; Device: Ankle foot orthosis from competitor 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee flexion angle during gait
Maximum, minimum and range of motion of the knee flexion angle during gait.
Measured: At delivery
Hip flexion angle during gait
Maximum, minimum and range of motion of the hip flexion angle during gait.
Measured: At delivery
Minimum foot clearance
Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing.
Measured: At delivery
Comfort of participants with orthosis
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
Measured: At delivery
Easy to put on orthosis
Easy to put on is measured with a Likert scale from 1 (very difficult) to 5 (very easy).
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start19 Jul 2021
- Primary completion30 Dec 2022
- Study completion28 Jun 2023
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- TOPMED
- Sponsor type
- University, hospital or other
- Collaborators
- Turbomed Orthotics Inc., Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Sponsor
- Investigators
- Edith Martin, PhD, Principal investigator, TOPMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163782
- Sponsor's protocol ID
- RD-19-0276_OptOrPi
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2021
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop
- ClinicalTrials.gov ID
- NCT05163782
- Acronym / sponsor ID
- RD-19-0276_OptOrPi
- Conditions
- Foot Drop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- TOPMEDUniversity, hospital or other
- Collaborators
- Turbomed Orthotics Inc., Natural Sciences and Engineering Research Council, Canada
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 20 Dec 2021 (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.
The objective of this research is to compare the new ankle foot orthosis (AFO) with prior support developed by Turbomed, with the AFO with posterior support from Turbomed as well as two competing AFOs currently on the market.
With this research, we seek to answer the following questions:
- Is the new AFO as biomechanically efficient as the AFOs currently on the market?
- Is the new AFO more comfortable than the AFO currently on the market?
- Is the new AFO easier to put on and attach than the AFOs currently on the market?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with foot drop | Experimental | Device: New ankle foot orthosis with anterior support, Device: Ankle foot orthosis with anterior support, Device: Ankle foot orthosis from competitor 1, Device: Ankle foot orthosis from competitor 2People with left or right foot drop |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Foot drop following surgery or an accident (functional calf, without contracture and not spastic)
- Foot drop following a Cerebral Vascular Accident (with or without spasticity, mild to moderate)
- Ability to stand and walk alone without technical assistance
- Ability to communicate comfort/discomfort
Key exclusion criteria (1 listed)
- Sore to one of the feet
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 |
|---|---|---|
| New ankle foot orthosis with anterior supportNew ankle foot orthosis with anterior support developed by Turbomed | Device | People with foot drop |
| Ankle foot orthosis with anterior supportAnkle foot orthosis with anterior support from Turbomed | Device | People with foot drop |
| Ankle foot orthosis from competitor 1Ankle foot orthosis with posterior support from competitor 1 | Device | People with foot drop |
| Ankle foot orthosis from competitor 2Ankle foot orthosis with posterior support from competitor 2 | Device | People with foot drop |
Primary outcome
Knee flexion angle during gait
Time frame: At delivery
Maximum, minimum and range of motion of the knee flexion angle during gait.
Hip flexion angle during gait
Time frame: At delivery
Maximum, minimum and range of motion of the hip flexion angle during gait.
Minimum foot clearance
Time frame: At delivery
Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing.
Comfort of participants with orthosis
Time frame: At delivery
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
Easy to put on orthosis
Time frame: At delivery
Easy to put on is measured with a Likert scale from 1 (very difficult) to 5 (very easy).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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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.
Edith Martin, PhD principal investigator
TOPMED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New ankle foot orthosis with anterior support, Ankle foot orthosis with anterior support and Ankle foot orthosis from competitor 1 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 14 Sep 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee flexion angle during gait (time frame: At delivery). The study lists 5 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 14 Sep 2023.