Recruiting

AFOs vs. Digital AFOs

Sponsor:

Holland Bloorview Kids Rehabilitation Hospital

Code:

NCT06828653

Conditions

Flaccid Paresis

Spastic Paresis

Cerebral Palsy

Stroke

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

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)

Study Details

Brief summary:

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.

Conditions

Flaccid Paresis

Spastic Paresis

Cerebral Palsy

Stroke

Spinal Cord Injury

Study ID

NCT06828653

Start date

Sep 5, 2025

Status verified date

Nov, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

Part A First Wear Period: Traditional AFO(s)

Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.

Part A First Wear Period: Digital AFO(s)

Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.

Part A Second Wear Period: Traditional AFO(s)

Participants wear traditionally produced AFOs during Weeks 4 through 6.

Part A Second Wear Period: Digital AFO(s)

Participants wear digitally produced AFOs during Weeks 4 through 6.

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

Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.

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

Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.

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 and Locations

Central contacts

Calvin Ngan, PhD

416-425-6220cngan@hollandbloorview.ca

Gloria Lee, MSc

416-425-6220glee@hollandbloorview.ca

Locations

Holland Bloorview Kids Rehabilitation Hospital

Recruiting

Toronto, Ontario, Canada, M4G1R8

Contacts

Calvin Ngan, PhD

416-425-6220cngan@hollandbloorview.ca

Gloria Lee, MSc

416-425-6220glee@hollandbloorview.ca

Principal Investigator:

Jan Andrysek, P.Eng, PhD

More Information

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Keywords

  • Ankle foot orthosis
  • ankle foot orthoses
  • digital ankle foot orthoses
  • digital technology
  • 3D scanning
  • 3D printing
  • randomized control trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital on 2025-11-20.