Clinical trial NCT06828653: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Flaccid Paresis
Spastic Paresis
Cerebral Palsy
Stroke
Spinal Cord Injury
Spina Bifida
Traumatic Peripheral Nerve Injury
Keywords: Ankle foot orthosis
ankle foot orthoses
digital ankle foot orthoses
digital technology
3D scanning
3D printing
randomized control trial
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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.

Primary outcomes:
measure: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
timeFrame: From the shape capture visit until the end of the study at week 14
Secondary outcomes:
measure: Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)
timeFrame: From Week 1 until Week 6 of the study
measure: Orthotics Prosthetics User's Survey (OPUS)
timeFrame: From Week 1 until Week 6 of the study
measure: 10-metre Walk Test
timeFrame: From the shape capture visit until the end of the study at Week 14
measure: Timed Up and Go (TUG)
timeFrame: From the shape capture visit until the end of the study at Week 14
measure: Goal Attainment Scale (GAS)
timeFrame: From the shape capture appointment until the participant receives their devices at Week 1
measure: AFO Challenge
timeFrame: From the shape capture visit until the end of the study at Week 14
measure: Orthotist Satisfaction Questionnaire
timeFrame: From the shape capture visit until the end of the crossover period at Week 6
measure: Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)
timeFrame: From the shape capture visit until the end of the crossover period at Week 6
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Boundless Biomechanical Bracing
state: Ontario
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Bloorview Research Institute
name: Jan Andrysek, P.Eng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bloorview Research Institute
name: Virginia Wright, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: