NCT06828653

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Sep 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Sep 2025Mar 2027

First Submitted

Initial submission to the registry

February 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

September 5, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

February 3, 2025

Last Update Submit

November 18, 2025

Conditions

Flaccid ParesisSpastic ParesisCerebral PalsyStrokeSpinal Cord InjurySpina BifidaTraumatic Peripheral Nerve Injury

Keywords

Ankle foot orthosisankle foot orthosesdigital ankle foot orthosesdigital technology3D scanning3D printingrandomized control trial

Outcome Measures

Primary Outcomes (1)

  • Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)

    Evaluates patient satisfaction related to assistive technology and services rendered. This questionnaire is commonly used in assessing performance of AFOs and other orthotic devices.

    From the shape capture visit until the end of the study at week 14

Secondary Outcomes (8)

  • Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)

    From Week 1 until Week 6 of the study

  • Orthotics Prosthetics User's Survey (OPUS)

    From Week 1 until Week 6 of the study

  • 10-metre Walk Test

    From the shape capture visit until the end of the study at Week 14

  • Timed Up and Go (TUG)

    From the shape capture visit until the end of the study at Week 14

  • Goal Attainment Scale (GAS)

    From the shape capture appointment until the participant receives their devices at Week 1

  • +3 more secondary outcomes

Study Arms (4)

Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear

ACTIVE COMPARATOR

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.

Device: Part A First Wear Period: Traditional AFO(s)Device: Part A Second Wear Period: Digital AFO(s)Device: Part B Long-term Evaluation Period: Traditional AFO(s)

Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear

EXPERIMENTAL

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.

Device: Part A First Wear Period: Digital AFO(s)Device: Part A Second Wear Period: Traditional AFO(s)Device: Part B Long-term Evaluation Period: Digital AFO(s)

Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear

ACTIVE COMPARATOR

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.

Device: Part A First Wear Period: Traditional AFO(s)Device: Part A Second Wear Period: Digital AFO(s)Device: Part B Long-term Evaluation Period: Digital AFO(s)

Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear

ACTIVE COMPARATOR

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.

Device: Part A First Wear Period: Digital AFO(s)Device: Part A Second Wear Period: Traditional AFO(s)Device: Part B Long-term Evaluation Period: Traditional AFO(s)

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: Traditional AFO(s) wear first; Part B: Digital AFO(s) wearPart A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear
Part A First Wear Period: Digital AFO(s)DEVICE

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

Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wearPart A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear
Part A Second Wear Period: Traditional AFO(s)DEVICE

Participants wear traditionally produced AFOs during Weeks 4 through 6.

Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wearPart A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear
Part A Second Wear Period: Digital AFO(s)DEVICE

Participants wear digitally produced AFOs during Weeks 4 through 6.

Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wearPart A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear
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 A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wearPart A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear
Part B Long-term Evaluation Period: Digital AFO(s)DEVICE

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

Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wearPart A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boundless Biomechanical Bracing

Mississauga, Ontario, L4W5A8, Canada

NOT YET RECRUITING

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyStrokeSpinal Cord InjuriesSpinal Dysraphism

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and InjuriesNeural Tube DefectsNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jan Andrysek, P.Eng, PhD

    Bloorview Research Institute

    PRINCIPAL INVESTIGATOR

  • Virginia Wright, PT, PhD

    Bloorview Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Calvin Ngan, PhD

CONTACT

416-425-6220cngan@hollandbloorview.ca

Gloria Lee, MSc

CONTACT

416-425-6220glee@hollandbloorview.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 14, 2025

Study Start

September 5, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)