Digital versus traditional ankle-foot orthoses for people with lower limb weakness

Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function

We will try if ankle-foot braces made with 3D scanning and printing work as well as traditional plaster-cast braces for people with leg weakness or stiffness from conditions like stroke or cerebral palsy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 8 Years and up
• Sex: All
• Sponsor: Holland Bloorview Kids Rehabilitation Hospital (other)
• Locations: 2 sites (Mississauga, Ontario and 1 other locations)
• Trial ID: NCT06828653 on ClinicalTrials.gov

What this trial studies

This feasibility trial compares AFOs produced by traditional plaster-cast methods with AFOs produced using digital workflows (3D scanning and digital fabrication) in people with flaccid or spastic paresis. Participants aged 8 and older who already ambulate and require a custom AFO will wear both types during defined wear periods to compare fit, function, and satisfaction. The study collects clinical measures of walking/function, patient-reported satisfaction, and the time and costs associated with each production method. Results will inform a larger randomized trial and determine whether digital production can offer similar outcomes with greater efficiency.

Who should consider this trial

Good fit: Ideal candidates are ambulatory people aged 8 or older with flaccid or spastic lower-limb paresis (e.g., from cerebral palsy, stroke, spinal cord injury or peripheral nerve injury) who need a custom articulating, rigid, or ESR AFO and meet Ontario Assistive Devices Program funding criteria.

Not a fit: Patients whose primary AFO need is for wound management, those with insensate feet or prior foot ulcers, non-ambulatory individuals, or first-time AFO users are unlikely to benefit from the comparisons in this trial.

Why it matters

Potential benefit: If successful, digital production could deliver AFOs faster and at lower cost while providing the same functional benefit as traditional devices.

How similar studies have performed: Small pilot studies and clinical reports suggest 3D-scanned and digitally fabricated AFOs can match traditional devices for fit and function, but high-quality comparative trials remain limited.

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Where this trial is running

Mississauga, Ontario and 1 other locations

• Boundless Biomechanical Bracing — Mississauga, Ontario, Canada (NOT_YET_RECRUITING)
• Holland Bloorview Kids Rehabilitation Hospital — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Jan Andrysek, P.Eng, PhD — Bloorview Research Institute
• Study coordinator: Calvin Ngan, PhD

Conditions: Flaccid Paresis, Spastic Paresis, Cerebral Palsy, Stroke, Spinal Cord Injury, Spina Bifida, Traumatic Peripheral Nerve Injury, Ankle foot orthosis