Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
时间窗: From the shape capture visit until the end of the study at week 14
Evaluates patient satisfaction related to assistive technology and services rendered. This questionnaire is commonly used in assessing performance of AFOs and other orthotic devices.
次要结局
- Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)(From the shape capture visit until the end of the crossover period at Week 6)
- Orthotics Prosthetics User's Survey (OPUS)(From Week 1 until Week 6 of the study)
- 10-metre Walk Test(From the shape capture visit until the end of the study at Week 14)
- Timed Up and Go (TUG)(From the shape capture visit until the end of the study at Week 14)
- Goal Attainment Scale (GAS)(From the shape capture appointment until the participant receives their devices at Week 1)
- AFO Challenge(From the shape capture visit until the end of the study at Week 14)
- Orthotist Satisfaction Questionnaire(From the shape capture visit until the end of the crossover period at Week 6)