3D-Printed Mobile Phone Holder for Individuals With Upper Limb Impairments

NCT07561944 | Not Yet Recruiting

• 1 other identifier: TMU-JIRBN202510077
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Limb Dysfunction; Hand Function Impairment; Musculoskeletal Disorders Affecting Hand Function; Difficulty Operating Smartphones Due to Upper Limb Impairment

Outcome Measures

Primary Outcomes (1)

• Smartphone Functional Performance Test

  A task-based performance assessment designed based on Fairman et al. (2025) and Lu et al. (2017) 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. Higher performance indicates improved smartphone-operating ability when using the 3D-printed assistive device.

  Baseline and 1 week after intervention

Secondary Outcomes (5)

• Modified Ashworth Scale (MAS)

  Baseline and 1 week

• Active Range of Motion (AROM) of Shoulder, Elbow, Wrist, and Fingers

  Baseline and 1 week

• NASA Task Load Index (NASA-TLX)

  Baseline and 1 week

• Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)

  1 week

• Daily Usage and Activity Log

  Daily for 1 week

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, New Taipei, 235, Taiwan

Location

Related Publications (20)

• Widehammar, C., Lidström, H., & Hermansson, L. (2019). Environmental barriers to participation and facilitators for use of three types of assistive technology devices. Assistive technology, 31(2), 68-76. https://doi.org/10.1080/10400435.2017.1363828

  BACKGROUND

• Pollock, A., Farmer, S. E., Brady, M. C., Langhorne, P., Mead, G. E., Mehrholz, J., & Van Wijck, F. (2014). Interventions for improving upper limb function after stroke. Cochrane database of systematic reviews(11). https://doi.org/10.1002/14651858.CD010820.pub2

  RESULT

• Marrie, R. A., Cutter, G. R., Tyry, T., Cofield, S. S., Fox, R., & Salter, A. (2017). Upper limb impairment is associated with use of assistive devices and unemployment in multiple sclerosis. Multiple sclerosis and related disorders, 13, 87-92. https://doi.org/10.1016/j.msard.2017.02.013

  RESULT

• MA, L., & PAN, Z. (2018). The Chinese version of the subjective load assessment method and the US National aeronautics and space administration task load index scales for assessing the reliability and validity of physicians' mental loads in tertiary hospitals. Chinese General Practice, 21(33), 4127. https://doi.org/10.12114/j.issn.1007-9572.2018.00.236

  RESULT

• Lu, E. C., Wang, R., Huq, R., Gardner, D., Karam, P., Zabjek, K., Hébert, D., Boger, J., & Mihailidis, A. (2011). Development of a robotic device for upper limb stroke rehabilitation: A user-centered design approach. Paladyn, Journal of Behavioral Robotics, 2(4), 176-184. https://doi.org/10.2478/s13230-012-0009-0

  RESULT

• Kim, J. J., Lee, J., Shin, J., & He, M. (2022). How are high-tech assistive devices valued in an aging society? Exploring the use and non-use values of equipment that aid limb disability. Technology in Society, 70, 102013. https://doi.org/10.1016/j.techsoc.2022.102013

  RESULT

• Khantan, M., Avery, M., Aung, P. T., Zarin, R. M., Hammelef, E., Shawki, N., Serruya, M. D., & Napoli, A. (2023). The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment. Journal of NeuroEngineering and Rehabilitation, 20(1), 103. https://doi.org/10.1186/s12984-023-01228-2

  RESULT

• Jinghong, C., & Hu, X. (2024). Mobile Phone Accessibility Solution for People with Upper Limb Dysfunction. Human Factors in Design, Engineering, and Computing, 159(159). https://doi.org/10.54941/ahfe1005653

  RESULT

• Hart, S. G., & Staveland, L. E. (1988). Development of NASA-TLX (Task Load Index): results of empirical and theoretical research. In Advances in psychology (Vol. 52, pp. 139-183). Elsevier. https://doi.org/10.1016/S0166-4115(08)62386-9

  RESULT

• Hands., A. (2025). Active Hands: Gripping aids for disabled people. Active Hands. https://www.activehands.com/

  RESULT

• Godeau, D., Fadel, M., & Descatha, A. (2022). Factors associated with limitations in daily life and at work in a population with shoulder pain. BMC musculoskeletal disorders, 23(1), 777. https://doi.org/10.1186/s12891-022-05638-6

  RESULT

• Gerhardt JJ, Rondinelli RD. Goniometric techniques for range-of-motion assessment. Phys Med Rehabil Clin N Am. 2001 Aug;12(3):507-27.

  PMID: 11478185 RESULT

• Fitzpatrick, A. P., Mohanned, M. I., Collins, P. K., & Gibson, I. (2017). Design of a patient specific, 3D printed arm cast. KnE Engineering, 135-142.

  RESULT

• Equip2Adapt. (n.d.). Cell phone accessibility. Equip2Adapt. https://equip2adapt.com/blog/cell-phone-accessibility/ Fairman, A. D., Indradhirmaya, F. A., Osal, R. B., & Saptono, A. (2025). Iterative user-centered design of the mobile device assessment tool (MoDAT). Technologies, 13(8), 358. https://doi.org/10.3390/technologies13080358 Fitzpatrick, A. P., Mohanned, M. I., Collins, P. K., & Gibson, I. (2017). Design of a patient specific, 3D printed arm cast. KnE Engineering, 135-142. Gerhardt, J. J., Rondinelli, R. D. J. P. m., & America, r. c. o. N. (2001). Goniometric techniques for range-of-motion assessment. 12(3), 507-528. Godeau, D., Fadel, M., & Descatha, A. (2022). Factors associated with limitations in daily life and at work in a population with shoulder pain. BMC musculoskeletal disorders, 23(1), 777. https://doi.org/10.1186/s12891-022-05638-6 Hands., A. (2025). Active Hands: Gripping aids for disabled people. Active Hands. https://www.activehands.com/ Hart, S. G., & Staveland, L. E. (1988). Development of NASA-TLX (Task Load Index): results of empirical and theoretical research. In Advances in psychology (Vol. 52, pp. 139-183). Elsevier. https://doi.org/10.1016/S0166-4115(08)62386-9 Hunzeker, M., & Ozelie, R. (2021). A Cost-Effective Analysis of 3D Printing Applications in Occupational Therapy Practice. The Open Journal of Occupational Therapy, 9(1), 1-12. iAccessibility. (n.d). Hawkeye Access. https://www.iaccessibility.com/apps/mobility/index.cgi/product?ID=288 Jang, H.-Y., Chung, D., Oh, E., & Hong, G.-R. S. (2025). Experiences of individuals with severe disabilities using assistive devices: A qualitative study. Disability and Health Journal, 101833. https://doi.org/10.1016/j.dhjo.2025.101833 Janson, R., Burkhart, K., Firchau, C., Hicks, K., Pittman, M., Yopps, M., Hatfield, S., & Garabrant, A. (2020). Three-dimensional printed assistive devices for addressing occupational performance issues of the hand: A case report. Journal of Hand Th

  RESULT

• Dorrington, P., Wilkinson, C., Tasker, L., & Walters, A. (2016). User-centered design method for the design of assistive switch devices to improve user experience, accessibility, and independence. Journal of Usability Studies, 11(2).

  RESULT

• Chan, N. H., & Ng, S. S. (2025). Contribution of Perceived Upper Limb Function to the Participation and Activity Levels Among Community-Dwelling People With Chronic Stroke. Annals of Rehabilitation Medicine. https://doi.org/10.5535/arm.240122

  RESULT

• Bonanno, M., Saracino, B., Ciancarelli, I., Panza, G., Manuli, A., Morone, G., & Calabrò, R. S. (2025). Assistive technologies for individuals with a disability from a neurological condition: A narrative review on the multimodal integration. Healthcare,

  RESULT

• Batkuldinova, K., Abilgaziyev, A., Shehab, E., & Ali, M. H. (2021). The recent development of 3D printing in developing lower-leg exoskeleton: A review. Materials Today: Proceedings, 42, 1822-1828. https://doi.org/10.1016/j.matpr.2020.12.191

  RESULT

• Baronio G, Harran S, Signoroni A. A Critical Analysis of a Hand Orthosis Reverse Engineering and 3D Printing Process. Appl Bionics Biomech. 2016;2016:8347478. doi: 10.1155/2016/8347478. Epub 2016 Aug 9.

  PMID: 27594781 RESULT

• Alghadir, A. H., Gabr, S. A., Rizk, A. A., Alghadir, T., Alghadir, F., & Iqbal, A. (2025). Smartphone addiction and musculoskeletal associated disorders in university students: biomechanical measures and questionnaire survey analysis. European Journal of Medical Research, 30(1), 274. https://doi.org/10.1186/s40001-025-02413-w

  RESULT

Study Officials

• Fen-Ling Kuo, Master

  Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University

  STUDY CHAIR

Central Study Contacts

Fen-Ling Kuo, Master

CONTACT

+88622490088; 08655@s.tmu.edu.tw

Chieh-Yu Pan, Master

CONTACT

022490088; 08411@s.tmu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Taipei Medical University Shuang Ho Hospital

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)