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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Holland Bloorview Kids Rehabilitation Hospital
  Toronto, Ontario, Canada Recruiting
• Boundless Biomechanical Bracing
  Mississauga, Ontario, Canada Not yet recruiting

Study contacts

• Principal investigator: Jan Andrysek, P.Eng, PhD — Bloorview Research Institute
• Study coordinator: Calvin Ngan, PhD
• Email: cngan@hollandbloorview.ca
• Phone: 416-425-6220

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gait and Achilles Tendon Properties in Spastic Paresis

  This study tests how the Achilles tendon and calf muscle function during walking in people with spastic weakness after stroke or spinal cord injury, compared with healthy individuals.

  Recruiting Nantes University Hospital · Nantes · NCT07467382

• Targeting the plantaris tendon during surgery to correct ankle equinus in children

  This trial tests whether cutting the small plantaris tendon, together with standard calf-lengthening surgery, helps children aged 4–17 with ankle equinus walk and use their feet better.

  Recruiting University of Alberta · Edmonton, Alberta · NCT07090057

• How VR Can Make a Virtual Body Feel Real

  This study tests different immersive virtual reality techniques to see which best makes a person feel the virtual body as their own, including in people with spinal cord injury or stroke.

  Recruiting IRCCS Eugenio Medea · Bosisio Parini, Lecco · NCT07870044

• Spatial StimelMD for upper-limb recovery after stroke or traumatic brain injury

  This trial will test whether adding the Spatial StimelMD device to standard rehabilitation helps adults with upper-limb weakness after stroke or traumatic brain injury improve arm movement.

  Recruiting Motion Informatics LTD · Haifa · NCT07404761

• Combining non-invasive brain and spinal cord stimulation to improve arm and hand function

  This study tests whether pairing non-invasive brain stimulation (tDCS) with spinal cord stimulation (tSCS) during a cognitive-motor task can improve sensorimotor and cognitive-motor function in people with cervical spinal cord injury or stroke compared with each stimulation alone or sham.

  Recruiting at 2 sites Phase 2 Centre National de la Recherche Scientifique, France · Bordeaux and 1 other locations · NCT07334977

• Neuro20 electrical stimulation suit to improve autonomic control, muscle performance, and walking after amputation or neurologic injury

  This will test whether wearing the Neuro20 electrical stimulation suit helps people at least one week after an amputation or neurologic injury (stroke, spinal cord injury, or brain injury) improve autonomic function, muscle strength, and walking.

  Recruiting Brooks Rehabilitation · Jacksonville, Florida and 1 other locations · NCT07164846

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.