Development and Validation of a New Wrist Orthosis by 3D Printing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in pain during treatment from baseline at day 14
研究概览
简要总结
In order to offer a new product improving the healing and/or rehabilitation of injuries or injuries to the wrist and hand, Médicus is seeking to develop a new orthosis for the wrist and hand by 3D printing. This project will focus on the development of an orthosis related to carpal tunnel syndrome as well as droopy hand. Among the issues to be addressed in this development proposal, the investigators find: 1) Identification of the best methodology for taking digital impressions; design of an orthosis with the following characteristics: (i) no external attachment system, (ii) spiral design with a thumb ring, (iii) manufacturing by 3D printing and (iv) a cost of less than $150 ;3) Performing technical and clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 18 and 70 years old
- •Ability to accurately communicate comfort and discomfort,
- •Carpal tunnel syndrome, or
- •de Quervain's tenosynovitis, or
- •Drop hand, or
- •Ulnar nerve damage
- •Rhizarthrosis, or
- •Tendinopathy of the thumb
- •And/or ulnar gale
排除标准
- •- Spasticity in the upper limbs
- •Paralysis, Insensitivity of the upper limbs
- •Neuromuscular pathology affecting the upper limbs
结局指标
主要结局
Change in pain during treatment from baseline at day 14
时间窗: Baseline and day 14
Pain measure via 1-5 rating, possible scores range from1 (no pain) to 5 (worst possible pain). Change = (Day 14 score - baseline score)
次要结局
- Difficulty in donning the orthosis(Each day during 2 weeks of intervention)
- Satisfaction on ease of donning(Day 14 of intervention)
- Satisfaction on ease of doffing(Day 14 of intervention)
- aesthetic satisfaction rating at baseline(Baseline)
- Comfort(Each day during 2 weeks of intervention)
- Weight satisfaction rating at day 14 of intervention(Day 14 of intervention)
- material quality satisfaction rating at day 14 of intervention(Day 14 of intervention)
- Weight satisfaction rating at baseline(Baseline)
- material quality satisfaction rating at baseline(Baseline)
- Functional disability evaluation of the upper member(Day 14 of intervention)
- aesthetic satisfaction rating at day 14 of intervention(Day 14 of intervention)