Design and Implementation of a 3D-Printed Mobile Phone Holder Selection and Fitting Process for Individuals With Upper Limb Functional Impairments
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Smartphone Functional Performance Test
研究概览
简要总结
Individuals with upper limb functional impairments, such as those resulting from stroke, spinal cord injury, musculoskeletal disorders, or degenerative joint disease, often experience difficulties operating smartphones. Standard devices typically require bilateral, precise fine motor control, which can limit independence, participation, and access to digital communication for this population. Although assistive products such as phone stands, straps, or styluses are available, they are often designed as "one-size-fits-all," lack individualization, and may not be well integrated into daily life.
Three-dimensional (3D) printing offers advantages of customization, modularity, low cost, and rapid production, and may support better matching between users and assistive devices. However, in clinical practice, the use of 3D-printed assistive technology is constrained by the lack of an integrated resource platform and standardized fitting procedures.
This exploratory intervention study aims to develop a 3D assistive device selection interface and a standardized fitting process for smartphone-related devices targeting adults with upper limb dysfunction. Approximately 30 outpatients will be recruited from a regional teaching hospital in northern Taiwan and will receive a 1-week intervention using a 3D-printed mobile phone holder or related assistive device, with occupational therapist support. Pre- and post-intervention assessments will examine smartphone task performance and satisfaction with the assistive technology. Feasibility, usability, and preliminary effectiveness will be evaluated to inform the development of a sustainable clinical service model.
详细描述
Upper limb dysfunction due to neurological, musculoskeletal, or degenerative conditions frequently interferes with the performance of fine motor tasks, including smartphone operation. Many individuals with unilateral weakness, limited range of motion, pain, or grip instability find it difficult to hold a phone securely, touch the screen accurately, or perform multi-step operations such as dialing, messaging, or taking photos. As smartphones have become central tools for communication, information access, and social participation, these limitations can widen the "digital divide" and negatively affect independence and quality of life.
Although a variety of commercial assistive devices exist (e.g., generic phone stands, straps, styluses, and gripping aids), they are often designed for the "average user" and may not accommodate severe deformities, contractures, or complex motor coordination problems. Many users and clinicians must improvise or modify existing devices, which is time-consuming and may compromise stability and safety. Clinical decision-making regarding assistive device selection frequently relies on individual therapist experience rather than standardized procedures or objective criteria, and patients often lack access to systematic information about available options, features, and indications.
Three-dimensional (3D) printing provides a promising avenue for developing lightweight, modular, and customizable assistive devices that can be tailored to each user's anatomy and functional needs. Prior research has demonstrated that 3D-printed assistive devices can improve functional performance, reduce pain, and increase satisfaction in populations with upper limb impairments. However, in routine rehabilitation practice, the implementation of 3D-printed assistive technology is hindered by (1) the absence of an integrated platform that consolidates design models, indications, and material/safety guidance, and (2) the lack of standardized fitting workflows and validated evaluation tools, which limits reproducibility and wider adoption across therapists and settings.
Objectives
This study is designed as an exploratory intervention to:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Currently receiving occupational therapy in the Department of Physical Medicine and Rehabilitation.
- •Onset of condition > 3 months.
- •Presence of upper-limb functional impairment that causes difficulty or limitations in smartphone use.
- •Able to understand instructions for using the assistive device.
- •Montreal Cognitive Assessment (MoCA) score > 24.
排除标准
- •Age younger than 18 years.
- •Severe visual or hearing impairments that would affect the ability to perform smartphone tasks.
- •Unstable medical condition that may interfere with participation in the study.
研究组 & 干预措施
3D-Printed Assistive Device Group
Participants will use a 3D-printed smartphone assistive device for at least 30 minutes daily for 1 week. Therapists will provide two intervention sessions for instruction, activity adjustment, and monitoring. Participants will record daily usage and upload photos via an online platform to support adherence and follow-up.
结局指标
主要结局
Smartphone Functional Performance Test
时间窗: Baseline and 1 week after intervention
A task-based performance assessment designed to evaluate the efficiency of smartphone hardware operations. Tasks include: (1) calling a contact, (2) dialing a number, (3) answering a call, (4) sending a text message, and (5) taking a photo. Outcome metrics include completion time, number of steps, error rate, and step completeness. Each task is scored on a scale from 0 to 6, with higher scores indicating better smartphone-operating performance.
次要结局
- Modified Ashworth Scale (MAS)(Baseline and 1 week)
- Active Range of Motion (AROM) of Shoulder, Elbow, Wrist, and Fingers(Baseline and 1 week)
- Daily Usage and Activity Log(Daily for 1 week)
- NASA Task Load Index (NASA-TLX)(Baseline and 1 week)
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)(1 week)
研究者
Fen Ling Kuo
Taipei Medical University Shuang Ho Hospital
Taipei Medical University Shuang Ho Hospital