Comparing Digitally and Traditionally Made Ankle Foot Orthoses

Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Study ID
NCT06828653
Status
Recruiting
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Conditions

  • Cerebral Palsy
  • Flaccid Paresis
  • Spastic Paresis
  • Spina Bifida
  • Spinal Cord Injury
  • Stroke
  • Traumatic Peripheral Nerve Injury

Eligibility Criteria

Sex
ALL
Age
8 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

First listed
Feb 14, 2025
Start date
Sep 5, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear
    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.
  • Experimental: Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear
    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.
  • Active Comparator: Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear
    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.
  • Active Comparator: Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear
    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.

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 ]

Central Contacts

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