Идёт набор NCT06828653

Comparing Digitally and Traditionally Made Ankle Foot Orthoses

Без фазы С лечением Flaccid Paresis Spastic Paresis Cerebral Palsy Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Part A First Wear Period: Traditional AFO(s), Part A First Wear Period: Digital AFO(s), Part A Second Wear Period: Traditional AFO(s), Part A Second Wear Period: Digital AFO(s).
Кому может быть актуально: Состояния в реестре: Flaccid Paresis, Spastic Paresis, Cerebral Palsy, Stroke. Базовые параметры: от 8 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Устройство Part A First Wear Period: Traditional AFO(s)
Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.
Устройство Part A First Wear Period: Digital AFO(s)
Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.
Устройство Part A Second Wear Period: Traditional AFO(s)
Participants wear traditionally produced AFOs during Weeks 4 through 6.
Устройство Part A Second Wear Period: Digital AFO(s)
Participants wear digitally produced AFOs during Weeks 4 through 6.
Устройство Part B Long-term Evaluation Period: Traditional AFO(s)
Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.
Устройство Part B Long-term Evaluation Period: Digital AFO(s)
Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.

Первичные конечные точки

Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) [Срок оценки: From the shape capture visit until the end of the study at week 14]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

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).