About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 design

Treatments tested in this trial

  • 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)
  • Part B Long-term Evaluation Period: Digital AFO(s)

Treatment groups

50 Participants
are divided into 4 treatment groups

Locations

2
Boundless Biomechanical BracingL4W5A8, MississaugaOntario, Canada
Holland Bloorview Kids Rehabilitation HospitalM4G1R8, TorontoOntario, Canada

Sponsors and collaborators

Holland Bloorview Kids Rehabilitation Hospital

Lead sponsor