Flaccid ParesisNCT06828653
Comparing Digitally and Traditionally Made Ankle Foot Orthoses
A study testing Part A First Wear Period: Traditional AFO(s), Part A First Wear Period: Digital AFO(s) and Part A Second Wear Period: Traditional AFO(s) in people with Flaccid Paresis and Spastic Paresis, run by Holland Bloorview Kids Rehabilitation Hospital at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Flaccid Paresis, Spastic Paresis, Cerebral Palsy
- What is being tested?
- Part A First Wear Period: Traditional AFO(s), Part A First Wear Period: Digital AFO(s) and Part A Second Wear Period: Traditional AFO(s)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Sep 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
Boundless Biomechanical Bracing
Mississauga, Ontario, L4W5A8
Anne Whitney, MSc, 905-602-0650, anne@boundlessbracing.com
- Recruiting
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G1R8
Calvin Ngan, PhD, 416-425-6220 ext. 6340, cngan@hollandbloorview.ca
Gloria Lee, MSc, 416-425-6220 ext. 3342, glee@hollandbloorview.ca
About this study
Official title: Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function
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.
Read the detailed description
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.
- Conditions
- Flaccid Paresis, Spastic Paresis, Cerebral Palsy, Stroke, Spinal Cord Injury, Spina Bifida
- Being tested
- Part A First Wear Period: Traditional AFO(s), Part A First Wear Period: Digital AFO(s), Part A Second Wear Period: Traditional AFO(s), Part A Second Wear Period: Digital AFO(s), Part B Long-term Evaluation Period: Traditional AFO(s)
- Keywords
- Ankle foot orthosis, ankle foot orthoses, digital ankle foot orthoses, digital technology, 3D scanning, 3D printing, randomized control trial
- Medical subject headings
- Cerebral Palsy, Stroke, Spinal Cord Injuries, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part A First Wear Period: Traditional AFO(s)Device
Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.
Part A First Wear Period: Digital AFO(s)Device
Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.
Part A Second Wear Period: Traditional AFO(s)Device
Participants wear traditionally produced AFOs during Weeks 4 through 6.
Part A Second Wear Period: Digital AFO(s)Device
Participants wear digitally produced AFOs during Weeks 4 through 6.
Part B Long-term Evaluation Period: Traditional AFO(s)Device
Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.
Part B Long-term Evaluation Period: Digital AFO(s)Device
Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
| 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. Receives: 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) |
| 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. Receives: 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) |
| Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear | Active comparator | 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the shape capture visit until the end of the study at week 14
Secondary outcomes (8)
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.
Measured: 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.
Measured: From Week 1 until Week 6 of the study
10-metre Walk Test
Timed walk test
Measured: From the shape capture visit until the end of the study at Week 14
Timed Up and Go (TUG)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the shape capture visit until the end of the crossover period at Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start5 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flaccid ParesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Andrysek, P.Eng, PhD, Principal investigator, Bloorview Research InstituteVirginia Wright, PT, PhD, Principal investigator, Bloorview Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828653
- Sponsor's protocol ID
- 703
- Status last verified
- Nov 2025
- First submitted
- 3 Feb 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function
- ClinicalTrials.gov ID
- NCT06828653
- Acronym / sponsor ID
- 703
- Conditions
- Flaccid Paresis, Spastic Paresis, Cerebral Palsy, Stroke, Spinal Cord Injury, Spina Bifida
- Keywords
- Ankle foot orthosis, ankle foot orthoses, digital ankle foot orthoses, digital technology, 3D scanning, 3D printing, randomized control trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear | Active comparator | 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 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. |
| Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear | Experimental | 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 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 | 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 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 | 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 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part A First Wear Period: Traditional AFO(s)Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3. | Device | Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear, Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear |
| Part A First Wear Period: Digital AFO(s)Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3. | Device | Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear, Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear |
| Part A Second Wear Period: Traditional AFO(s)Participants wear traditionally produced AFOs during Weeks 4 through 6. | Device | Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear, Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear |
| Part A Second Wear Period: Digital AFO(s)Participants wear digitally produced AFOs during Weeks 4 through 6. | Device | Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear, Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear |
| Part B Long-term Evaluation Period: Traditional AFO(s)Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14. | Device | Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear, Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear |
| Part B Long-term Evaluation Period: Digital AFO(s)Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14. | Device | Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear, Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear |
Primary outcome
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time frame: From the shape capture visit until the end of the study at week 14
Evaluates patient satisfaction related to assistive technology and services rendered. This questionnaire is commonly used in assessing performance of AFOs and other orthotic devices.
8 secondary outcomes
Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)
Time frame: From Week 1 until Week 6 of the study
Orthotics Prosthetics User's Survey (OPUS)
Time frame: From Week 1 until Week 6 of the study
10-metre 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)
Time frame: From the shape capture appointment until the participant receives their devices at Week 1
AFO Challenge
Time frame: From the shape capture visit until the end of the study at Week 14
Orthotist Satisfaction Questionnaire
Time frame: From the shape capture visit until the end of the crossover period at Week 6
Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)
Time frame: From the shape capture visit until the end of the crossover period at Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Andrysek, P.Eng, PhD principal investigator
Bloorview Research Institute
Virginia Wright, PT, PhD principal investigator
Bloorview Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Part A First Wear Period: Traditional AFO(s), Part A First Wear Period: Digital AFO(s) and Part A Second Wear Period: Traditional AFO(s) in people with Flaccid Paresis and Spastic Paresis, run by Holland Bloorview Kids Rehabilitation Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Calvin Ngan, PhD (416-425-6220 ext. 6340, cngan@hollandbloorview.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) (time frame: From the shape capture visit until the end of the study at week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.