An interventional study of Part A First Wear Period: Traditional AFO(s) and Part A First Wear Period: Digital AFO(s) in Flaccid Paresis, Spastic Paresis and Cerebral Palsy, sponsored by Holland Bloorview Kids Rehabilitation Hospital. Recruiting at 2 sites in Canada. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Holland Bloorview Kids Rehabilitation Hospital · Not applicable, Interventional, and Health services research
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.
This study is designed to compare two methods of creating ankle-foot orthoses (AFOs), which are devices used to support the lower limbs in people with mobility impairments due to conditions like stroke or cerebral palsy. The traditional method involves manually creating a mold from a plaster cast of the patient's limb, which is time-consuming and labor-intensive. The new method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly.
The purpose of the study is to test whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally, but with greater efficiency and at a lower cost. The research will gather data on patient satisfaction, the functionality of the AFOs, and the costs associated with each method. This will help determine if the digital method can be a viable alternative to traditional AFO production, potentially leading to better patient care and reduced healthcare costs.
The study poses the overarching research question: Can digitally produced ankle-foot orthoses (AFOs) achieve similar positive clinical outcomes to traditionally fabricated AFOs while being more efficient and cost-effective? The primary objective of this feasibility study is to inform the design of a larger randomized controlled trial (RCT) that will comprehensively address this question.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 50 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Holland Bloorview Kids Rehabilitation Hospital is the lead sponsor of 64 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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.
Device: Part A First Wear Period: Traditional AFO(s) · Device: Part A Second Wear Period: Digital AFO(s) · Device: Part B Long-term Evaluation Period: Traditional AFO(s)
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.
Device: Part A First Wear Period: Digital AFO(s) · Device: Part A Second Wear Period: Traditional AFO(s) · Device: Part B Long-term Evaluation Period: Digital AFO(s)
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.
Device: Part A First Wear Period: Traditional AFO(s) · Device: Part A Second Wear Period: Digital AFO(s) · Device: Part B Long-term Evaluation Period: Digital AFO(s)
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.
Device: Part A First Wear Period: Digital AFO(s) · Device: Part A Second Wear Period: Traditional AFO(s) · Device: Part B Long-term Evaluation Period: Traditional AFO(s)
Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.
Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.
Participants wear traditionally produced AFOs during Weeks 4 through 6.
Participants wear digitally produced AFOs during Weeks 4 through 6.
Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.
Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Evaluates patient satisfaction related to assistive technology and services rendered. This questionnaire is commonly used in assessing performance of AFOs and other orthotic devices.
Time frame: From the shape capture visit until the end of the study at week 14
Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)
Designed and validated to assess orthotic users' ability to perform activities related to movement, locomotion, and/or postural transitions.
Time frame: From Week 1 until Week 6 of the study
Orthotics Prosthetics User's Survey (OPUS)
Assesses function, satisfaction, and quality of life of individuals using orthotic or prosthetic devices. Its Lower Extremity Functional Status component will be used since it pertains specifically to the individual's functional abilities and limitations.
Time frame: From Week 1 until Week 6 of the study
10-metre Walk Test
Timed walk test
Time frame: From the shape capture visit until the end of the study at Week 14
Timed Up and Go (TUG)
Time frame: From the shape capture visit until the end of the study at Week 14
Goal Attainment Scale (GAS)
Creating biomechanical (alignment/dynamic) goals that AFOs are designed to treat. Will be applied to both types of AFOs. Goal achievement rating will be based on a modification of the GAS 5-level rating system (levels -2 to 0 only) after AFO fitting is complete
Time frame: From the shape capture appointment until the participant receives their devices at Week 1
AFO Challenge
A new six-item measure that was created by the Holland Bloorview team for this study to capture any functionally important differences in balance linked with AFO type across a spectrum of client abilities.
Time frame: From the shape capture visit until the end of the study at Week 14
Orthotist Satisfaction Questionnaire
Evaluate orthotists' satisfaction with the AFO fabrication and fitting process.
Time frame: From the shape capture visit until the end of the crossover period at Week 6
Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)
Designed and validated to assess orthotic users' ability to perform activities related to movement, locomotion, and/or postural transitions.
Time frame: From the shape capture visit until the end of the crossover period at Week 6
Plan to share: No
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Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 15 months is above that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
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