Comparing Digitally and Traditionally Made Ankle Foot Orthoses

Official title

Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function

Overview

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.

Detailed 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.

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.

Primary outcome measures

• 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]

Secondary outcome measures (8)

• Orthotic Patient-Reported Outcomes - Mobility (OPRO-M) [Time frame: From Week 1 until Week 6 of the study]
• Orthotics Prosthetics User's Survey (OPUS) [Time frame: From Week 1 until Week 6 of the study]
• 10-metre Walk Test [Time frame: From the shape capture visit until the end of the study at Week 14]
• Timed Up and Go (TUG) [Time frame: From the shape capture visit until the end of the study at Week 14]
• Goal Attainment Scale (GAS) [Time frame: From the shape capture appointment until the participant receives their devices at Week 1]
• AFO Challenge [Time frame: From the shape capture visit until the end of the study at Week 14]
• Orthotist Satisfaction Questionnaire [Time frame: From the shape capture visit until the end of the crossover period at Week 6]
• Orthotic Patient-Reported Outcomes - Mobility (OPRO-M) [Time frame: From the shape capture visit until the end of the crossover period at Week 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Health services research

Study locations

Canada · 2 centers

• Boundless Biomechanical Bracing — Mississauga
• Holland Bloorview Kids Rehabilitation Hospital — Toronto

Identifiers

NCT: NCT06828653 · 703

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗