Actively Recruiting
Feasibility Randomized Controlled Trial Comparing Digitally and Traditionally Produced Ankle Foot Orthoses for People With Lower Limb Mobility Impairments
Led by Holland Bloorview Kids Rehabilitation Hospital · Updated on 2025-11-20
50
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two methods of making ankle-foot orthoses (AFOs), devices that support lower limbs in people with mobility issues caused by conditions like stroke or cerebral palsy. The traditional method involves making a mold from a plaster cast, which is slow and requires much work. The newer method uses digital technology like 3D scanning and printing, aiming to be faster and less costly while providing similar benefits. Participants will wear both types of AFOs in a randomized, crossover design. In Part A, they wear one type of AFO for 3 weeks, then switch to the other type for another 3 weeks. In Part B, they wear one type continuously for 8 weeks. The study collects data on patient satisfaction, mobility, and cost to see if digital AFOs are a viable alternative to traditional ones. During the study, participants undergo various assessments including satisfaction surveys, mobility tests like the 10-metre Walk Test and Timed Up and Go, and goal attainment evaluations. Questionnaires and orthotist feedback are gathered throughout up to week 14. This helps researchers understand how each AFO type affects function, satisfaction, and overall outcomes over time.
CONDITIONS
Brief Title
Comparing Digitally and Traditionally Made Ankle Foot Orthoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 8 years or older
- Have flaccid or spastic paresis from cerebral palsy, stroke, spinal cord injury, spina bifida, or traumatic peripheral nerve injury causing lower limb mobility problems
- Require a custom articulating, rigid, or energy storage and return ankle-foot orthosis (AFO) for one or both legs
- Able to walk independently, with or without walking aids
- Able to complete questionnaires with some guidance
- Eligible for AFO funding through the Assistive Devices Program (ADP)
You will not qualify if you...
- Primary AFO goal includes wound management
- AFO not used for walking
- Have insensate feet or history of foot ulcers
- First-time AFO users who have never used an AFO before
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 weeks
Participants wear ankle-foot orthoses (AFOs) produced either traditionally or digitally in a crossover design to compare clinical benefits and efficiency of production methods.
Weekly visits during the 6-week crossover wear period
Duration - 8 weeks
Participants wear either traditionally or digitally produced AFOs for an extended period to evaluate longer-term outcomes including satisfaction, mobility, and device performance.
Visits every 1 to 2 weeks during the 8-week follow-up wear period
Trial Site Locations
Total: 2 locations
1
Boundless Biomechanical Bracing
Mississauga, Ontario, Canada, L4W5A8
Not Yet Recruiting
2
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G1R8
Actively Recruiting
Research Team
C
Calvin Ngan, PhD
G
Gloria Lee, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
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