To Assess the Utility of the Point Digit in a Clinical Take-home Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 9
- 主要终点
- Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
研究概览
简要总结
This study will allow us to assess whether the Point Digit confers functional and psychological benefit to persons with partial hand amputations in an unconstrained environment. The use of the Point Digit outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Partial hand amputees with absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met.
- •Fluent in English
- •Individuals aged 18 or greater
排除标准
- •Significant cognitive deficits as determined upon clinical evaluation
- •Significant neurological deficits as determined upon clinical evaluation
- •Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
- •Uncontrolled pain or phantom pain impacting full participation in the study as determined upon occupational therapist evaluation
- •Serious uncontrolled medical problems as judged by the project therapist.
结局指标
主要结局
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
时间窗: ~Day 60: with prosthesis, 60 days post-fitting
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Disability of the Arm, Shoulder and Hand (DASH)
时间窗: ~Day 60: with prosthesis, 60 days post-fitting
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.
Southampton Hand Assessment Procedure (SHAP)
时间窗: ~Day 60: with prosthesis, 60 days post-fitting
The Southampton Hand Assessment Procedure (SHAP) is a clinically validated hand function test. Originally developed to assess the effectiveness of upper limb prostheses, the SHAP has now been applied to assessment of musculoskeletal and neurological conditions. Scale Title: Index of Function. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
EuroQol-5 Dimension (EQ-5D-5L)
时间窗: ~Day 60: with prosthesis, 60 days post-fitting
Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
次要结局
未报告次要终点