NCT06828653 - Comparing Digitally and Traditionally Made Ankle Foot Orthoses | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

March 31, 2027

Conditions

Flaccid ParesisSpastic ParesisCerebral PalsyStrokeSpinal Cord InjurySpina BifidaTraumatic Peripheral Nerve Injury

Interventions

DEVICE

Part A First Wear Period: Traditional AFO(s)

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

DEVICE

Part A First Wear Period: Digital AFO(s)

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

DEVICE

Part A Second Wear Period: Traditional AFO(s)

Participants wear traditionally produced AFOs during Weeks 4 through 6.

DEVICE

Part A Second Wear Period: Digital AFO(s)

Participants wear digitally produced AFOs during Weeks 4 through 6.

DEVICE

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

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

DEVICE

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

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

Trial Locations (2)

Boundless Biomechanical Bracing, Mississauga

Holland Bloorview Kids Rehabilitation Hospital, Toronto

All Listed Sponsors

lead

Holland Bloorview Kids Rehabilitation Hospital

OTHER