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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear | Active Comparator | 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. |
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| Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear | Experimental | 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. |
|
| Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear | Active Comparator | 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. |
|
| Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part A First Wear Period: Traditional AFO(s) | Device | Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the shape capture visit until the end of the study at week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Week 1 until Week 6 of the study |
| Orthotics Prosthetics User's Survey (OPUS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Calvin Ngan, PhD | Contact | 416-425-6220 | 6340 | cngan@hollandbloorview.ca |
| Gloria Lee, MSc | Contact | 416-425-6220 | 3342 | glee@hollandbloorview.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jan Andrysek, P.Eng, PhD | Bloorview Research Institute | Principal Investigator |
| Virginia Wright, PT, PhD | Bloorview Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boundless Biomechanical Bracing | Not yet recruiting | Mississauga | Ontario | L4W5A8 | Canada |
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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.
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| Part A First Wear Period: Digital AFO(s) | Device | Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3. |
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| Part A Second Wear Period: Traditional AFO(s) | Device | Participants wear traditionally produced AFOs during Weeks 4 through 6. |
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| Part A Second Wear Period: Digital AFO(s) | Device | Participants wear digitally produced AFOs during Weeks 4 through 6. |
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| Part B Long-term Evaluation Period: Traditional AFO(s) | Device | Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14. |
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| Part B Long-term Evaluation Period: Digital AFO(s) | Device | Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14. |
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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. |
| From Week 1 until Week 6 of the study |
| 10-metre Walk Test | Timed walk test | From the shape capture visit until the end of the study at Week 14 |
| Timed Up and Go (TUG) | 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 | 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. | 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. | 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. | From the shape capture visit until the end of the crossover period at Week 6 |
| Holland Bloorview Kids Rehabilitation Hospital | Recruiting | Toronto | Ontario | M4G1R8 | Canada |
|
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D020521 | Stroke |
| D013119 | Spinal Cord Injuries |
| D016135 | Spinal Dysraphism |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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