Digital vs Traditional Ankle Foot Orthoses for Muscular Weakness
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two methods for making ankle-foot orthoses (AFOs), which assist individuals with muscle weakness in their legs to walk better. One method employs the traditional plaster mold technique, while the other utilizes new digital technology, such as 3D printing. The researchers aim to determine if digital AFOs can provide the same benefits as traditional ones, with potentially faster and more cost-effective production. Suitable participants have muscle weakness in their lower limbs due to conditions like cerebral palsy or stroke and already use AFOs to aid independent walking. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance AFO production and accessibility.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that these methods of creating Ankle Foot Orthoses are safe?
Research has shown that ankle-foot orthoses (AFOs), both digital and traditional, are generally safe for use. Studies examining the impact of AFOs on walking have found them to be well-tolerated, with no major safety concerns reported.
Digital AFOs utilize 3D scanning and printing, offering a quicker and cheaper alternative to traditional methods. Although this approach is newer, no evidence suggests it is less safe than traditional AFOs.
Both types of AFOs aim to help individuals with muscle weakness improve their walking. Overall, AFOs are considered a safe option for managing walking difficulties.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it compares digital and traditional Ankle Foot Orthoses (AFOs) for addressing muscular weakness. Traditional AFOs are typically custom-made using molds of the patient's foot and ankle, which can be time-consuming and less precise. In contrast, digital AFOs leverage advanced technology for a more personalized fit, potentially improving comfort and effectiveness. By comparing both methods, the trial aims to uncover which approach offers better support and mobility for patients, paving the way for enhanced rehabilitation strategies.
What evidence suggests that digital AFOs are effective for muscular weakness?
Research has shown that ankle-foot orthoses (AFOs) can assist individuals with weak calf muscles by making walking easier and faster. In this trial, participants will use both traditional and digital AFOs. The newer digital AFOs employ 3D scanning and printing, potentially making them quicker and cheaper to produce. While traditional AFOs perform well, studies suggest that digital AFOs might provide similar walking assistance. Early findings indicate that digital methods could offer more precise customization for each person, potentially enhancing comfort and function. Overall, both traditional and digital AFOs hold promise for those needing walking support.12678
Who Is on the Research Team?
Jan Andrysek, P.Eng, PhD
Principal Investigator
Bloorview Research Institute
Virginia Wright, PT, PhD
Principal Investigator
Bloorview Research Institute
Are You a Good Fit for This Trial?
This trial is for individuals with conditions like muscular weakness, spinal cord injury, cerebral palsy, peripheral neuropathy, and similar nerve or muscle issues. It's also for those who have experienced delayed wound healing after a stroke or have nerve damage from injuries.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants wear either traditional or digital AFOs for 3 weeks, then crossover to the other type for another 3 weeks
Treatment Part B
Participants continue wearing the assigned AFO type for an additional 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ankle Foot Orthoses
Trial Overview
The study compares ankle foot orthoses (AFOs) made traditionally by hand-casting to those created using digital methods like 3D scanning and printing. Participants will wear both types of AFOs in different periods to assess their effectiveness.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants wear digitally produced AFO(s) for 3 weeks, and will then crossover to wear traditional AFO(s) for another 3 weeks. In Part B of the study, participants will wear digital AFO(s) for 8 weeks.
Participants wear traditionally produced AFO(s) for 3 weeks, and will then crossover to wear digital AFO(s) for another 3 weeks. In Part B of the study, participants will wear traditional AFO(s) for 8 weeks.
Participants wear traditionally produced AFO(s) for 3 weeks, and will then crossover to wear digital AFO(s) for another 3 weeks. In Part B of the study, participants will wear digital AFO(s) for 8 weeks.
Participants wear digitally produced AFO(s) for 3 weeks, and will then crossover to wear traditional AFO(s) for another 3 weeks. In Part B of the study, participants will wear traditional AFO(s) for 8 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Holland Bloorview Kids Rehabilitation Hospital
Lead Sponsor
Citations
1.
withpower.com
withpower.com/trial/digital-vs-traditional-ankle-foot-orthoses-for-muscular-weakness-73f7bDigital vs Traditional Ankle Foot Orthoses for Muscular ...
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Results: The results indicated that increased translational stiffness significantly reduced inversion angles to safer levels, though direction–dependent effects ...
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The purpose of this exploratory study is to ascertain whether PTs treating IwCVA know of and use these orthotic. OMs targeting the ankle and ...
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