Three-dimensional Printed Orthoses for Improving Daily Functioning in Chronic Hand Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change from baseline in performance of ADL on the custom short form of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System - Upper extremity (DF-PROMIS-UE) at 4 months post-intervention.
研究概览
简要总结
In persons with chronic hand conditions, orthoses are often prescribed to improve daily-life functioning. In most cases, orthoses are custom manufactured based on a plaster hand model, which is a time-consuming and labor-intensive process. It has been demonstrated that the production time to custom manufacture hand orthoses can be greatly reduced by using three-dimensional (3D) scanning and printing, offering a promising cost-effective alternative to conventional costum manufactured hand orthoses. However, before setting up a cost-effectiveness study in persons with chronic hand conditions, insight into the effectiveness of 3D-printed orthoses on performance of activities of daily living (ADL) is needed, as well as insight into potential cost reductions. To date, this information is largely unknown. The aims of this feasibility study are 1) to collect data on the preliminary effectiveness of 3D-printed orthoses on performance of ADL, satisfaction with the orthosis and quality of life compared to conventional orthoses in persons with chronic hand conditions, and 2) to compare the production time and costs of 3D-printed orthoses with conventional orthoses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a chronic hand-wrist condition due to an injury, or a musculoskeletal disorder, neuromuscular disorder, or neurological disorder;
- •Minimum age of 18 years;
- •Currently wearing a conventional custom manufactured hand orthosis (including a wrist-orthosis, wrist/thumb orthosis or thumb orthosis) for permanent use;
- •Indicated for a new hand orthosis.
排除标准
- •Already wearing a 3D-printed orthosis
- •Wearing a silver wrist-orthosis, wrist/thumb orthosis or thumb orthosis
- •Wearing an orthosis prescribed for a dysfunctional hand;
- •Wearing a broken orthosis;
- •Wearing the orthosis only at night;
- •Worsening of disease;
- •Insufficient mastery of the Dutch language.
结局指标
主要结局
Change from baseline in performance of ADL on the custom short form of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System - Upper extremity (DF-PROMIS-UE) at 4 months post-intervention.
时间窗: 2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention
The short form DF-PROMIS-UE contains 25 items from the DF-PROMIS-UE 46-item bank. Patients will rate how easily they can perform each activity on a 5-point scale, ranging from "without any difficulty" (score 4 or 5) to "unable to do" (score 1). For each activity, the question was added whether participants use their orthosis for that specific activity. The total score will be expressed as a T-score, which is a standardized score, with 50 representing the average score of the US general population and 10 being its standard deviation (SD). Note. For this study, the reliability of the DF-PROMIS-UE in persons with chronic hand conditions will be determined.
次要结局
- Change from baseline in performance of ADL, overall hand function, pain, work, performance, aesthetics, and satisfaction on the Michigan Hand Questionnaire-Dutch Language version (MHQ-DLV) at 4 months post-intervention.(2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention)
- Change from baseline in satisfaction assessed with the Dutch version of the Client Satisfaction with Device (CSD) module of the Orthotics and Prosthetics User's Survey (OPUS) at 4 months post-intervention.(2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention)
- Change from baseline in satisfaction assessed with the Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) at 4 months post-intervention(Baseline; 1 month post-intervention; 4 months post-intervention)
- Change from baseline in personal goals at 4 month post-intervention.(Baseline; 1 month post-intervention, 4 months post-intervention)
- Change from baseline in orthosis use at 4 month post-intervention.(Baseline; 1 month post-intervention, 4 months post-intervention)
- Change in quality of life on the 5-dimension 5-level EuroQol (EQ-5D-5L) at 4 months post-intervention.(Baseline; 1 month post-intervention, 4 months post-intervention)
- Number of visits for fabrication of the 3D orthosis(From start of the intervention up to delivery of the orthosis)
- Production time of the orthosis (in minutes).(From start of the intervention up to delivery of the orthosis)
- Production costs of the orthosis (in euro).(From start of the intervention up to delivery of the orthosis)
- Patient and therapist experiences with the 3D orthosis(1 month post-treatment)
研究者
Merel Brehm
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)