3D-printed breathing-powered prosthetic arm for children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Stage I:
研究概览
简要总结
Most upper limb (UL) prosthetics are generally not affordable for a vast majority of patients in low and middle-income countries. Also, the current prosthetics are often not appropriate for application in these more challenging environments. Despite significant advances in prosthetic technology, the most popular and affordable UL prosthetics for adults and children remain body-powered (BP). A BP prosthesis uses a Bowden cable (like the standard bicycle brake cables) to connect movements of the upper extremity (UE) to movements of the terminal device (hook-shaped or anthropomorphic). This technology is more than 100 years old, and it still dominates much of the market. However, the use of cables severely limits/restricts the movement possibilities of the user. An exciting prospect is the ability to provide new customised, BP prosthetics that allow the patient to position the hand anywhere in space freely. This is particularly promising for children who have a lost or missing limb, as their prosthetic operating space should not be limited as they grow and develop.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Boy or girl, aged three years to 17 years including non-wearers of a prosthetic device.
- •Individuals with a bilateral level of amputation and non-disabled children (only Stage I).
- •The participant’s parent or the legal guardian is willing and able to give permission and informed assent for his or her ward’s participation in the study.
- •Be free of neurological and musculoskeletal pathology (apart from upper limb (UL) amputation or loss for prosthesis users, and as reported by the participants or their clinician) that would impair UL motor control during goal-oriented task execution in a seated position.
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Generally, any medical conditions, assessed by their treating healthcare professionals, that would contraindicate the use of our prosthetic arm prototypes, such as difficulties in breathing, skin abrasions, and musculoskeletal injuries.
- •Wounds or ulcers in the residuum.
- •Individuals with a transcarpal level of amputation (for Stage II).
结局指标
主要结局
Stage I:
时间窗: 36 months from the date of study approval
Stage II:
时间窗: 36 months from the date of study approval
– Qualitative feedback provided by the study participants and their parent(s) or legal guardian via a questionnaire; Researcher-observed data
时间窗: 36 months from the date of study approval
– Published outcome measures such as babySHAP, PUFI, and PODCI (or PedsQL) tests.
时间窗: 36 months from the date of study approval
次要结局
- Stage I:(– A questionnaire-based survey by the study participants and their parent(s) or legal guardian via questionnaires (QUEST 2.0 and Nagaraja et al. 2016).)