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Compares treatment options for Flaccid Paresis
Official title Comparing Digitally and Traditionally Made Ankle Foot Orthoses
ClinicalTrials.gov ID: NCT06828653
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join if
- 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...
- Participants must require a custom articulating, rigid, or energy storage and return (ESR) AFO to improve physical function for one or both sides...
- Participants must be able to ambulate independently, though the use of gait aids is permitted.
- Participants must be capable of completing questionnaires with no more than orienting guidance.
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mississauga, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mississauga, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.