Comparing Digitally and Traditionally Made Ankle Foot Orthoses

Holland Bloorview Kids Rehabilitation Hospital

Status: Enrolling

Conditions: Flaccid Paresis; Spina Bifida; Stroke; Traumatic Peripheral Nerve Injury; Cerebral Palsy; Spinal Cord Injury; Spastic Paresis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06828653

703

Details and patient eligibility

About

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.

Full description

This study is designed to compare two methods of creating ankle-foot orthoses (AFOs), which are devices used to support the lower limbs in people with mobility impairments due to conditions like stroke or cerebral palsy. The traditional method involves manually creating a mold from a plaster cast of the patient's limb, which is time-consuming and labor-intensive. The new method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly.

The purpose of the study is to test whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally, but with greater efficiency and at a lower cost. The research will gather data on patient satisfaction, the functionality of the AFOs, and the costs associated with each method. This will help determine if the digital method can be a viable alternative to traditional AFO production, potentially leading to better patient care and reduced healthcare costs.

The study poses the overarching research question: Can digitally produced ankle-foot orthoses (AFOs) achieve similar positive clinical outcomes to traditionally fabricated AFOs while being more efficient and cost-effective? The primary objective of this feasibility study is to inform the design of a larger randomized controlled trial (RCT) that will comprehensively address this question.

Enrollment: 50 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 4 patient groups

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

Active Comparator group

Description:

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.

Treatment:

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

Device: Part A First Wear Period: Traditional AFO(s)

Device: Part A Second Wear Period: Digital AFO(s)

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

Experimental group

Description:

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.

Treatment:

Device: Part A Second Wear Period: Traditional AFO(s)

Device: Part A First Wear Period: Digital 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 group

Description:

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.

Treatment:

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

Device: Part A First Wear Period: Traditional AFO(s)

Device: Part A Second Wear Period: Digital AFO(s)

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

Active Comparator group

Description:

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.

Treatment:

Device: Part A Second Wear Period: Traditional AFO(s)

Device: Part A First Wear Period: Digital AFO(s)

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