Upper Limb DysfunctionNCT07561944
3D-Printed Mobile Phone Holder for Individuals With Upper Limb Impairments
An observational study of Upper Limb Dysfunction and Hand Function Impairment, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Dysfunction, Hand Function Impairment, Musculoskeletal Disorders Affecting Hand Function
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2026to 30 Dec 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Medical University Shuang Ho Hospital
New Taipei City, New Taipei, 235
Fen-Ling Kuo, Master, 022490088, 08655@s.tmu.edu.tw
About this study
Official title: Design and Implementation of a 3D-Printed Mobile Phone Holder Selection and Fitting Process for Individuals With Upper Limb Functional Impairments
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.
Read the detailed description
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:
Develop an internal 3D assistive device selection interface (menu system) that consolidates smartphone-related assistive resources suitable for individuals with upper limb movement difficulties.
Establish a standardized fitting process (SOP) for smartphone operation supports (e.g., single-hand or bilateral phone holders).
Modify and modularize 5-8 commonly used smartphone assistive devices (e.g., holders, straps, desk or forearm-mounted supports) to enhance functional usability and convenience.
Evaluate the clinical feasibility and preliminary effectiveness of these devices in terms of functional performance, user satisfaction, and efficiency, and use these findings to inform a sustainable service model.
Study Design and Setting
The study adopts a single-group, pre-post exploratory intervention design. Participants will be recruited from the outpatient rehabilitation department of a regional teaching hospital in northern Taiwan. Eligible participants will be adults with upper limb functional impairments who experience difficulties using a smartphone and are able to follow instructions and provide informed consent.
Intervention
After baseline assessment, each participant will undergo a structured selection and fitting process using a 3D-printed smartphone assistive device (e.g., custom mobile phone holder or related support). An internal 3D device menu/interface will support therapist-patient joint decision-making based on functional needs and hand function status.
Participants will be instructed to use the assigned 3D-printed assistive device for at least 10 minutes per day over 1 week in their daily environment. During the intervention period, an occupational therapist will provide two individual follow-up sessions (approximately 15 minutes each) to:
Review the participant's functional abilities and goals.
Explain and demonstrate correct device use and recommended practice activities.
Monitor compensatory patterns, provide posture and movement corrections, and adjust the device or training tasks as needed.
Participants will be asked to complete a brief daily log documenting device usage (e.g., whether used, duration), activity examples, and any discomfort or adverse events.
Outcome Measures
Assessments will be conducted at baseline (pre-intervention) and at the end of the 1-week intervention (post-intervention) by trained occupational therapists who are not involved in the fitting process.
Primary outcomes will include:
Smartphone operation task performance, assessed through standardized tasks such as:
Searching the contact list and making a call
Dialing a phone number using the keypad
Answering a call
Sending a text or instant message
Taking a photo Performance metrics will include completion time, observable errors, and task completion.
Secondary outcomes will include:
User satisfaction with the assistive device, measured using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST).
Feasibility indicators, such as adherence to daily device use (from logs), therapist-rated fitting feasibility, and the occurrence and nature of adverse events.
Data Analysis
Descriptive statistics will be used to summarize participant characteristics, device use patterns, and feasibility indicators. Non-parametric tests will compare pre- and post-intervention functional performance and satisfaction scores. Adverse event rates will be calculated to describe safety and tolerability. Linear regression and general linear model-based univariate analyses may be used to explore associations between baseline factors and changes in functional outcomes, where appropriate. Statistical analyses will be performed using SPSS 26.0, with the significance level set at α < 0.05.
The findings of this exploratory trial will inform the refinement of the 3D-printed device library, the standardized fitting process, and the clinical workflow, with the long-term goal of developing a scalable and sustainable 3D-printed assistive technology service model for individuals with upper limb functional impairments.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 week after intervention
Secondary outcomes (5)
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.
Measured: Baseline and 1 week
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).
Measured: Baseline and 1 week
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.
Measured: Baseline and 1 week
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.
Measured: 1 week
Daily Usage and Activity Log
Participants record daily device usage duration, practice activities, and any adverse events (skin redness, pressure pain, slippage, pinching injury, etc.). Used to monitor adherence and safety throughout the intervention.
Measured: Daily for 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Upper Limb DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fen-Ling Kuo, Master, Study chair, Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561944
- Sponsor's protocol ID
- TMU-JIRBN202510077
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Widehammar C, Lidstrom H, Hermansson L. Environmental barriers to participation and facilitators for use of three types of assistive technology devices. Assist Technol. 2019;31(2):68-76. doi: 10.1080/10400435.2017.1363828. Epub 2017 Sep 13.
PubMed 28783455Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
PubMed 25387001Marrie RA, Cutter GR, Tyry T, Cofield SS, Fox R, Salter A. Upper limb impairment is associated with use of assistive devices and unemployment in multiple sclerosis. Mult Scler Relat Disord. 2017 Apr;13:87-92. doi: 10.1016/j.msard.2017.02.013. Epub 2017 Feb 20.
PubMed 28427709MA, 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
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
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
Khantan M, Avery M, Aung PT, Zarin RM, Hammelef E, Shawki N, Serruya MD, Napoli A. The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment. J Neuroeng Rehabil. 2023 Aug 4;20(1):103. doi: 10.1186/s12984-023-01228-2.
PubMed 37542335Jinghong, 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
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
Hands., A. (2025). Active Hands: Gripping aids for disabled people. Active Hands. https://www.activehands.com/
Godeau D, Fadel M, Descatha A. Factors associated with limitations in daily life and at work in a population with shoulder pain. BMC Musculoskelet Disord. 2022 Aug 15;23(1):777. doi: 10.1186/s12891-022-05638-6.
PubMed 35971096Gerhardt JJ, Rondinelli RD. Goniometric techniques for range-of-motion assessment. Phys Med Rehabil Clin N Am. 2001 Aug;12(3):507-27.
PubMed 11478185Fitzpatrick, A. P., Mohanned, M. I., Collins, P. K., & Gibson, I. (2017). Design of a patient specific, 3D printed arm cast. KnE Engineering, 135-142.
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
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).
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Implementation of a 3D-Printed Mobile Phone Holder Selection and Fitting Process for Individuals With Upper Limb Functional Impairments
- ClinicalTrials.gov ID
- NCT07561944
- Acronym / sponsor ID
- TMU-JIRBN202510077
- Conditions
- Upper Limb Dysfunction, Hand Function Impairment, Musculoskeletal Disorders Affecting Hand Function, Difficulty Operating Smartphones Due to Upper Limb Impairment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
Develop an internal 3D assistive device selection interface (menu system) that consolidates smartphone-related assistive resources suitable for individuals with upper limb movement difficulties.
Establish a standardized fitting process (SOP) for smartphone operation supports (e.g., single-hand or bilateral phone holders).
Modify and modularize 5-8 commonly used smartphone assistive devices (e.g., holders, straps, desk or forearm-mounted supports) to enhance functional usability and convenience.
Evaluate the clinical feasibility and preliminary effectiveness of these devices in terms of functional performance, user satisfaction, and efficiency, and use these findings to inform a sustainable service model.
Study Design and Setting
The study adopts a single-group, pre-post exploratory intervention design. Participants will be recruited from the outpatient rehabilitation department of a regional teaching hospital in northern Taiwan. Eligible participants will be adults with upper limb functional impairments who experience difficulties using a smartphone and are able to follow instructions and provide informed consent.
Intervention
After baseline assessment, each participant will undergo a structured selection and fitting process using a 3D-printed smartphone assistive device (e.g., custom mobile phone holder or related support). An internal 3D device menu/interface will support therapist-patient joint decision-making based on functional needs and hand function status.
Participants will be instructed to use the assigned 3D-printed assistive device for at least 10 minutes per day over 1 week in their daily environment. During the intervention period, an occupational therapist will provide two individual follow-up sessions (approximately 15 minutes each) to:
Review the participant's functional abilities and goals.
Explain and demonstrate correct device use and recommended practice activities.
Monitor compensatory patterns, provide posture and movement corrections, and adjust the device or training tasks as needed.
Participants will be asked to complete a brief daily log documenting device usage (e.g., whether used, duration), activity examples, and any discomfort or adverse events.
Outcome Measures
Assessments will be conducted at baseline (pre-intervention) and at the end of the 1-week intervention (post-intervention) by trained occupational therapists who are not involved in the fitting process.
Primary outcomes will include:
Smartphone operation task performance, assessed through standardized tasks such as:
Searching the contact list and making a call
Dialing a phone number using the keypad
Answering a call
Sending a text or instant message
Taking a photo Performance metrics will include completion time, observable errors, and task completion.
Secondary outcomes will include:
User satisfaction with the assistive device, measured using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST).
Feasibility indicators, such as adherence to daily device use (from logs), therapist-rated fitting feasibility, and the occurrence and nature of adverse events.
Data Analysis
Descriptive statistics will be used to summarize participant characteristics, device use patterns, and feasibility indicators. Non-parametric tests will compare pre- and post-intervention functional performance and satisfaction scores. Adverse event rates will be calculated to describe safety and tolerability. Linear regression and general linear model-based univariate analyses may be used to explore associations between baseline factors and changes in functional outcomes, where appropriate. Statistical analyses will be performed using SPSS 26.0, with the significance level set at α < 0.05.
The findings of this exploratory trial will inform the refinement of the 3D-printed device library, the standardized fitting process, and the clinical workflow, with the long-term goal of developing a scalable and sustainable 3D-printed assistive technology service model for individuals with upper limb functional impairments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Smartphone Functional Performance Test
Time frame: 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.
5 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Baseline and 1 week
Active Range of Motion (AROM) of Shoulder, Elbow, Wrist, and Fingers
Time frame: Baseline and 1 week
NASA Task Load Index (NASA-TLX)
Time frame: Baseline and 1 week
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time frame: 1 week
Daily Usage and Activity Log
Time frame: Daily for 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 28783455Widehammar C, Lidstrom H, Hermansson L. Environmental barriers to participation and facilitators for use of three types of assistive technology devices. Assist Technol. 2019;31(2):68-76. doi: 10.1080/10400435.2017.1363828. Epub 2017 Sep 13.
- Results publication: PubMed 25387001Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
- Results publication: PubMed 28427709Marrie RA, Cutter GR, Tyry T, Cofield SS, Fox R, Salter A. Upper limb impairment is associated with use of assistive devices and unemployment in multiple sclerosis. Mult Scler Relat Disord. 2017 Apr;13:87-92. doi: 10.1016/j.msard.2017.02.013. Epub 2017 Feb 20.
- Results publicationMA, 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
- Results publicationLu, 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
- Results publicationKim, 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
- Results publication: PubMed 37542335Khantan M, Avery M, Aung PT, Zarin RM, Hammelef E, Shawki N, Serruya MD, Napoli A. The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment. J Neuroeng Rehabil. 2023 Aug 4;20(1):103. doi: 10.1186/s12984-023-01228-2.
- Results publicationJinghong, 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
- Results publicationHart, 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
- Results publicationHands., A. (2025). Active Hands: Gripping aids for disabled people. Active Hands. https://www.activehands.com/
- Results publication: PubMed 35971096Godeau D, Fadel M, Descatha A. Factors associated with limitations in daily life and at work in a population with shoulder pain. BMC Musculoskelet Disord. 2022 Aug 15;23(1):777. doi: 10.1186/s12891-022-05638-6.
- Results publication: PubMed 11478185Gerhardt JJ, Rondinelli RD. Goniometric techniques for range-of-motion assessment. Phys Med Rehabil Clin N Am. 2001 Aug;12(3):507-27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fen-Ling Kuo, Master study chair
Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Dysfunction and Hand Function Impairment, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fen-Ling Kuo, Master (+88622490088, 08655@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smartphone Functional Performance Test (time frame: Baseline and 1 week after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561944, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.