Comparing 4 approaches for flaccid paresis
Official title: Comparing Digitally and Traditionally Made Ankle Foot Orthoses
Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function
- 4 groups
- Sites in Mississauga and Toronto
- Recruiting
Interventions (6)
- Medical device
Part A First Wear Period: Traditional AFO(s)
Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.
- Medical device
Part A First Wear Period: Digital AFO(s)
Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.
- Medical device
Part A Second Wear Period: Traditional AFO(s)
Participants wear traditionally produced AFOs during Weeks 4 through 6.
- Medical device
Part A Second Wear Period: Digital AFO(s)
Participants wear digitally produced AFOs during Weeks 4 through 6.
- Medical device
Part B Long-term Evaluation Period: Traditional AFO(s)
Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.
- Medical device
Part B Long-term Evaluation Period: Digital AFO(s)
Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.
Canadian Sites (2)
1 of 2 recruiting
- Recruiting
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario
- Not yet recruiting
Boundless Biomechanical Bracing
Mississauga, Ontario
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants must require a custom articulating, rigid, or energy storage and return (ESR) AFO to improve physical function for one or both sides (unilateral or bilateral).
- +Participants must be able to ambulate independently, though the use of gait aids is permitted.
- +Participants must be aged 8 years or older.
- +Participants should have either flaccid or spastic paresis resulting from conditions such as cerebral palsy, stroke, spinal cord injury, spina bifida, or traumatic peripheral nerve injury, leading to lower limb mobility impairments.
- +Participants must be capable of completing questionnaires with no more than orienting guidance.
- +Participants must meet the requirements to have their AFO funded by the Assistive Devices Program (ADP).
Exclusion
- −Clients for whom the primary goal of the AFO includes wound management.
- −Those whose AFO is not worn for ambulation.
- −Clients with insensate feet or a history of ulcerations.
- −First-time AFO users.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is looking at how care is delivered and organised, rather than at a treatment itself.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A, the comparison group, receives one or more of: Part A First Wear Period: Traditional AFO(s), Part A Second Wear Period: Digital AFO(s) and Part B Long-term Evaluation Period: Traditional AFO(s).
Registry label: A: Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear
Group B receives one or more of: Part A First Wear Period: Digital AFO(s), Part A Second Wear Period: Traditional AFO(s) and Part B Long-term Evaluation Period: Digital AFO(s).
Registry label: B: Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear
Group C, the comparison group, receives one or more of: Part A First Wear Period: Traditional AFO(s), Part A Second Wear Period: Digital AFO(s) and Part B Long-term Evaluation Period: Digital AFO(s).
Registry label: C: Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear
Group D, the comparison group, receives one or more of: Part A First Wear Period: Digital AFO(s), Part A Second Wear Period: Traditional AFO(s) and Part B Long-term Evaluation Period: Traditional AFO(s).
Registry label: D: Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 8 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50 people.
The study is currently expected to finish around March 2027.
The main measurement is taken over: From the shape capture visit until the end of the study at week 14.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) — measured over From the shape capture visit until the end of the study at week 14.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06828653 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Part A First Wear Period: Traditional AFO(s)Device
Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Part A First Wear Period: Digital AFO(s)Device
Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Part A Second Wear Period: Traditional AFO(s)Device
Participants wear traditionally produced AFOs during Weeks 4 through 6.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Part A Second Wear Period: Digital AFO(s)Device
Participants wear digitally produced AFOs during Weeks 4 through 6.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Part B Long-term Evaluation Period: Traditional AFO(s)Device
Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Part B Long-term Evaluation Period: Digital AFO(s)Device
Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 8 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 8 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From the shape capture visit until the end of the study at week 14.
The study as a whole is currently expected to finish around 2027-03-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Mississauga, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The research is being done to compare two methods of creating AFOs: 1. The traditional method, which involves manually creating a mold from a plaster cast of the client's limb. This is time-consuming and labor-intensive; and 2. The newer method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly. We want to know whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally.
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.