About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
This study will recruit adults with upper limb functional impairments who are currently receiving occupational therapy in the Department of Physical Medicine and Rehabilitation. Eligible participants must have an onset of more than three months, report difficulties or functional needs related to smartphone use due to upper limb impairment, and demonstrate adequate cognitive ability to follow instructions (Montreal Cognitive Assessment \[MoCA\] score \> 24). Individuals younger than 18 years, those with severe visual or hearing impairments, or those with unstable medical conditions that may interfere with participation will be excluded.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Smartphone Functional Performance Test
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.
Secondary outcomes
Modified Ashworth Scale (MAS)
Assesses upper-limb muscle tone on a 0-4 scale, where higher scores indicate more severe spasticity. Used to monitor whether muscle tone influences device use.
Active Range of Motion (AROM) of Shoulder, Elbow, Wrist, and Fingers
Angle goniometry measuring shoulder flexion (0-180°), abduction (0-180°), external rotation (0-90°), internal rotation (0-70°), and elbow flexion (0-150°). Greater ROM indicates better joint mobility (Gerhardt et al., 2001).
NASA Task Load Index (NASA-TLX)
A multidimensional subjective workload assessment measuring mental demand, physical demand, temporal demand, performance, effort, and frustration. Each domain is rated on a scale from 0 to 100. Higher scores indicate higher perceived workload.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
A user-rated questionnaire measuring satisfaction with assistive technology device characteristics, including dimensions, weight, ease of use, comfort, and effectiveness. Each item is rated on a 5-point Likert scale. Total scores range from 12 to 60, with higher scores indicating greater satisfaction with the assistive device.
Sponsors and contacts
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