Stroke3D-splintNCT07243314
Evaluating Functional Outcomes of 3D-Printed Splints in Post-Stroke Upper Limb Recovery
A study testing 3D Printed splint and conventional splint in people with Stroke and Stroke Rehabilitation, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
This study aims to evaluate the upper limb motor recovery using a 3D-printed dynamic orthosis compared to a conventional one as part of a rehabilitation program in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke Rehabilitation, Hemiparesis of the Upper Limb Following Stroke
- What is being tested?
- 3D Printed splint and conventional splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2025to 30 Sep 2027
- Phase
- Interventional
- 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
Who may be able to join
- Over 18 years old.
- Chronic stroke
- Upper limb hemiparalysis
- Ability to understand and follow orders and able to provide informed consent (Mini-Mental State Exam (MMSE) > 24)
- Upper-limb mild to moderate spasticity (Modified Ashworth Scale 1+ to 3 at the wrist).
- Not participating in other clinical or research studies at the same time
Who cannot join
- Had deficits in language or cognitive impairments that were likely to interfere with their cooperation in the study
- Deformity or presented with severe upper-limb contractures
- Inability to commit to the time requirement of the protocol.
- Unilateral neglect
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Sultan Bin Abdulaziz Humanitarian City
Riyadh, Riyadh Region, 13571
Arwa H Aloumi, +966556746668, irb@sbahc.org.sa
About this study
This study aims to evaluate the upper limb motor recovery using a 3D-printed dynamic orthosis compared to a conventional one as part of a rehabilitation program in individuals with chronic stroke.
The main question it seeks to answer:
Read more
Which type of dynamic splint (3D-printed or traditional), combined with the task-oriented therapy program, leads to greater improvement in affected upper-limb function, patient satisfaction, and usability in stroke patients? Researchers will compare these two types of dynamic splints.
Participants will:
Receive 20 sessions of task-oriented therapy combined with either a 3D-printed dynamic splint or a traditional dynamic splint.
Visit the clinic five times a week for a period of four weeks. Undergo assessments before and after the 4-week program.
Read the detailed description
Background: After a stroke, intensive motor rehabilitation is essential to improve upper limb function and independence. 3D-printed dynamic splints offer precise joint alignment, adjustable resistance, and enhanced comfort, facilitating repetitive, task-oriented practice and promoting neuroplasticity. To date, no studies have directly compared the effectiveness of 3D-printed dynamic splints with conventional dynamic splints combined with task-oriented therapy for improving upper limb function after stroke. Objectives: To evaluate the effects of 3D-printed versus conventional dynamic splints, both combined with task-oriented therapy, on upper limb motor recovery and patient satisfaction in chronic stroke patients. Methods: A randomized controlled trial will assign participants to either a 3D-printed splint + task-oriented therapy group or a conventional splint + therapy group. The intervention will last 4 weeks, with five 60-minute sessions per week, and daily splint use for 6 hours.
Inclusion Criteria: Adults ≥18 years with chronic stroke and upper limb hemiparesis, able to understand and follow instructions, MMSE ≥24, mild to moderate upper-limb spasticity, and not participating in other clinical or research studies simultaneously. Exclusion Criteria: Severe spasticity, upper limb deformities or contractures, unilateral neglect, or severe language or cognitive impairments.Outcomes: Primary outcomes: Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Wolf Motor Function Test (WMFT), Box and Block Test (BBT). Secondary outcomes: Motor Activity Log (MAL), Arabic version of Stroke Impact Scale (SIS-16), and Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0).
- Being tested
- 3D Printed splint, conventional splint
- Keywords
- stroke, Ischemic Stroke, Hemorrhagic Stroke, Hemiparesis, Splint, Dynamic Splint, Three-Dimensional Printing, 3D-Printed Splint, Orthosis, Task-Oriented, Traditional Dynamic Splint, Motor Function
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed splintDevice
Patients undergo 60-minute therapy sessions 5 times per week for 4 weeks, including stretching and task-oriented training.
Splint Protocol: A 3D-printed dynamic splint is worn during the 60-minute clinic session, plus an additional 5 hours daily on training days and 6 hours daily on non-training days
conventional splintDevice
Patients undergo 60-minute therapy sessions 5 times per week for 4 weeks, including stretching and task-oriented training.
Splint Protocol: A conventional dynamic splint is worn during the 60-minute clinic session, plus an additional 5 hours daily on training days and 6 hours daily on non-training days
| Study group | Role | What they receive |
|---|---|---|
| 3D-Printed Dynamic Splint Group | Experimental | will wear a 3D-printed dynamic splint at least 6 hours daily Receives: Device: 3D Printed splint |
| Dynamic Splint Group | Active comparator | will wear a conventional dynamic splint for at at least 6 hours Receives: Device: conventional splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test (WMFT)
The WMFT is a standardized assessment used to measure upper extremity motor ability through the performance of 17 tasks that include both functional and strength components. Rated using the 6-point scale ranging from 0 (no attempt) to 5 (normal movement). The total performance time and quality of movement are recorded, with lower scores indicating lower levels of functioning.
Measured: at baseline and after intervention (4 weeks)
Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
The FMA-UE is a comprehensive quantitative measure designed to evaluate motor function, coordination, and reflex activity of the affected upper limb following stroke. It uses a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 66 points for the upper extremity. It is considered the gold standard for assessment of upper limb motor recovery.
Measured: at baseline and after intervention (4 weeks)
Box and Block Test (BBT)
The BBT is a validated measure of gross manual dexterity that evaluates how many 1-inch wooden blocks a participant can transfer from one compartment to another within 60 seconds using one hand. The apparatus consists of a wooden box divided into two equal sections containing 150 small cubes. The test begins with the unaffected upper limb to allow practice and establish a baseline performance. Participants are then instructed to move as many blocks as possible, one at a time, over the partition within the time limit. The score is defined as the total number of blocks successfully transferred within 60 seconds.
Measured: at baseline and after intervention (4 weeks)
Secondary outcomes (3)
Motor Activity Log (MAL)
MAL is a validated, self-reported questionnaire that assesses the real-world use of the affected upper limb during activities of daily living. It consists of two subscales: the Amount of Use (AOU) and the Quality of Movement (QOM). Each subscale contains 30 items rated on a 6-point Likert scale. For the AOU subscale, participants rate how frequently they used their affected arm, from 0 ("did not use my weaker arm") to 5 ("used my weaker arm as often as before the stroke"). For the QOM subscale, participants rate how well the affected limb assisted in the task, from 0 ("my weaker arm was not used at all for that activity") to 5 ("the ability to use my weaker arm was as good as before the stroke").
Measured: at baseline and after intervention (4 weeks)
Arabic Version of Stroke Impact Scale (SIS-16)
The SIS-16 is a self-report tool designed to evaluate health-related quality of life among stroke survivors. It includes 16 items covering mobility, self-care, and hand function, rated on a 5-point Likert scale (1 = unable to do, 5 = not difficult at all). Higher scores represent a better level of health-related quality of life status for stroke patients.
Measured: at baseline and after intervention (4 weeks)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
QUEST 2.0 assesses user satisfaction with assistive devices and related services through 12 items divided into two subscales: device satisfaction and service satisfaction. Each item is rated on a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied)
Measured: Each session (5 times per week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study startNov 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Saud Alshammari, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243314
- Sponsor's protocol ID
- No.: 151-2025-IRB
- Other IDs
- Not found
- Acronym
- 3D-splint
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng Y, Liu G, Yu L, Wang Y, Fang Y, Shen Y, Huang X, Qiao L, Yang J, Zhang Y, Hua Z. Effects of a 3D-printed orthosis compared to a low-temperature thermoplastic plate orthosis on wrist flexor spasticity in chronic hemiparetic stroke patients: a randomized controlled trial. Clin Rehabil. 2020 Feb;34(2):194-204. doi: 10.1177/0269215519885174. Epub 2019 Nov 5.
PubMed 31686529Jeon HS, Woo YK, Yi CH, Kwon OY, Jung MY, Lee YH, Hwang S, Choi BR. Effect of intensive training with a spring-assisted hand orthosis on movement smoothness in upper extremity following stroke: a pilot clinical trial. Top Stroke Rehabil. 2012 Jul-Aug;19(4):320-8. doi: 10.1310/tsr1904-320.
PubMed 22750961Andringa AS, Van de Port IG, Meijer JW. Tolerance and effectiveness of a new dynamic hand-wrist orthosis in chronic stroke patients. NeuroRehabilitation. 2013;33(2):225-31. doi: 10.3233/NRE-130949.
PubMed 23949058Yang YS, Tseng CH, Fang WC, Han IW, Huang SC. Effectiveness of a New 3D-Printed Dynamic Hand-Wrist Splint on Hand Motor Function and Spasticity in Chronic Stroke Patients. J Clin Med. 2021 Sep 30;10(19):4549. doi: 10.3390/jcm10194549.
PubMed 34640564Chen ZH, Yang YL, Lin KW, Sun PC, Chen CS. Functional Assessment of 3D-Printed Multifunction Assistive Hand Device for Chronic Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2022;30:1261-1266. doi: 10.1109/TNSRE.2022.3173034. Epub 2022 May 17.
PubMed 35533167
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Functional Outcomes of 3D-Printed Splints in Post-Stroke Upper Limb Recovery
- ClinicalTrials.gov ID
- NCT07243314
- Acronym / sponsor ID
- 3D-splint / No.: 151-2025-IRB
- Keywords
- stroke, Ischemic Stroke, Hemorrhagic Stroke, Hemiparesis, Splint, Dynamic Splint, Three-Dimensional Printing, 3D-Printed Splint
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 21 Nov 2025 (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.
This study aims to evaluate the upper limb motor recovery using a 3D-printed dynamic orthosis compared to a conventional one as part of a rehabilitation program in individuals with chronic stroke.
The main question it seeks to answer:
Which type of dynamic splint (3D-printed or traditional), combined with the task-oriented therapy program, leads to greater improvement in affected upper-limb function, patient satisfaction, and usability in stroke patients? Researchers will compare these two types of dynamic splints.
Participants will:
Receive 20 sessions of task-oriented therapy combined with either a 3D-printed dynamic splint or a traditional dynamic splint.
Visit the clinic five times a week for a period of four weeks. Undergo assessments before and after the 4-week program.
Detailed description
Background: After a stroke, intensive motor rehabilitation is essential to improve upper limb function and independence. 3D-printed dynamic splints offer precise joint alignment, adjustable resistance, and enhanced comfort, facilitating repetitive, task-oriented practice and promoting neuroplasticity. To date, no studies have directly compared the effectiveness of 3D-printed dynamic splints with conventional dynamic splints combined with task-oriented therapy for improving upper limb function after stroke. Objectives: To evaluate the effects of 3D-printed versus conventional dynamic splints, both combined with task-oriented therapy, on upper limb motor recovery and patient satisfaction in chronic stroke patients. Methods: A randomized controlled trial will assign participants to either a 3D-printed splint + task-oriented therapy group or a conventional splint + therapy group. The intervention will last 4 weeks, with five 60-minute sessions per week, and daily splint use for 6 hours.
Inclusion Criteria: Adults ≥18 years with chronic stroke and upper limb hemiparesis, able to understand and follow instructions, MMSE ≥24, mild to moderate upper-limb spasticity, and not participating in other clinical or research studies simultaneously. Exclusion Criteria: Severe spasticity, upper limb deformities or contractures, unilateral neglect, or severe language or cognitive impairments.Outcomes: Primary outcomes: Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Wolf Motor Function Test (WMFT), Box and Block Test (BBT). Secondary outcomes: Motor Activity Log (MAL), Arabic version of Stroke Impact Scale (SIS-16), and Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-Printed Dynamic Splint Group | Experimental | Device: 3D Printed splintwill wear a 3D-printed dynamic splint at least 6 hours daily |
| Dynamic Splint Group | Active comparator | Device: conventional splintwill wear a conventional dynamic splint for at at least 6 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years old.
- Chronic stroke
- Upper limb hemiparalysis
- Ability to understand and follow orders and able to provide informed consent (Mini-Mental State Exam (MMSE) > 24)
- Upper-limb mild to moderate spasticity (Modified Ashworth Scale 1+ to 3 at the wrist).
Key exclusion criteria (4 listed)
- Had deficits in language or cognitive impairments that were likely to interfere with their cooperation in the study
- Deformity or presented with severe upper-limb contractures
- Inability to commit to the time requirement of the protocol.
- Unilateral neglect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Printed splintPatients undergo 60-minute therapy sessions 5 times per week for 4 weeks, including stretching and task-oriented training. Splint Protocol: A 3D-printed dynamic splint is worn during the 60-minute clinic session, plus an additional 5 hours daily on training days and 6 hours daily on non-training days | Device | 3D-Printed Dynamic Splint Group |
| conventional splintPatients undergo 60-minute therapy sessions 5 times per week for 4 weeks, including stretching and task-oriented training. Splint Protocol: A conventional dynamic splint is worn during the 60-minute clinic session, plus an additional 5 hours daily on training days and 6 hours daily on non-training days | Device | Dynamic Splint Group |
Primary outcome
Wolf Motor Function Test (WMFT)
Time frame: at baseline and after intervention (4 weeks)
The WMFT is a standardized assessment used to measure upper extremity motor ability through the performance of 17 tasks that include both functional and strength components. Rated using the 6-point scale ranging from 0 (no attempt) to 5 (normal movement). The total performance time and quality of movement are recorded, with lower scores indicating lower levels of functioning.
Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
Time frame: at baseline and after intervention (4 weeks)
The FMA-UE is a comprehensive quantitative measure designed to evaluate motor function, coordination, and reflex activity of the affected upper limb following stroke. It uses a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 66 points for the upper extremity. It is considered the gold standard for assessment of upper limb motor recovery.
Box and Block Test (BBT)
Time frame: at baseline and after intervention (4 weeks)
The BBT is a validated measure of gross manual dexterity that evaluates how many 1-inch wooden blocks a participant can transfer from one compartment to another within 60 seconds using one hand. The apparatus consists of a wooden box divided into two equal sections containing 150 small cubes. The test begins with the unaffected upper limb to allow practice and establish a baseline performance. Participants are then instructed to move as many blocks as possible, one at a time, over the partition within the time limit. The score is defined as the total number of blocks successfully transferred within 60 seconds.
3 secondary outcomes
Motor Activity Log (MAL)
Time frame: at baseline and after intervention (4 weeks)
Arabic Version of Stroke Impact Scale (SIS-16)
Time frame: at baseline and after intervention (4 weeks)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time frame: Each session (5 times per 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 21 Nov 2025.
- Results publication: PubMed 31686529Zheng Y, Liu G, Yu L, Wang Y, Fang Y, Shen Y, Huang X, Qiao L, Yang J, Zhang Y, Hua Z. Effects of a 3D-printed orthosis compared to a low-temperature thermoplastic plate orthosis on wrist flexor spasticity in chronic hemiparetic stroke patients: a randomized controlled trial. Clin Rehabil. 2020 Feb;34(2):194-204. doi: 10.1177/0269215519885174. Epub 2019 Nov 5.
- Results publication: PubMed 22750961Jeon HS, Woo YK, Yi CH, Kwon OY, Jung MY, Lee YH, Hwang S, Choi BR. Effect of intensive training with a spring-assisted hand orthosis on movement smoothness in upper extremity following stroke: a pilot clinical trial. Top Stroke Rehabil. 2012 Jul-Aug;19(4):320-8. doi: 10.1310/tsr1904-320.
- Results publication: PubMed 23949058Andringa AS, Van de Port IG, Meijer JW. Tolerance and effectiveness of a new dynamic hand-wrist orthosis in chronic stroke patients. NeuroRehabilitation. 2013;33(2):225-31. doi: 10.3233/NRE-130949.
- Results publication: PubMed 34640564Yang YS, Tseng CH, Fang WC, Han IW, Huang SC. Effectiveness of a New 3D-Printed Dynamic Hand-Wrist Splint on Hand Motor Function and Spasticity in Chronic Stroke Patients. J Clin Med. 2021 Sep 30;10(19):4549. doi: 10.3390/jcm10194549.
- Results publication: PubMed 35533167Chen ZH, Yang YL, Lin KW, Sun PC, Chen CS. Functional Assessment of 3D-Printed Multifunction Assistive Hand Device for Chronic Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2022;30:1261-1266. doi: 10.1109/TNSRE.2022.3173034. Epub 2022 May 17.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Printed splint and conventional splint in people with Stroke and Stroke Rehabilitation, run by King Saud University at 1 site in Saudi Arabia.
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 6 inclusion and 4 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 21 Nov 2025. 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 Saudi Arabia. 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 zainab S alshammari, physical therapist (+966532984967, 446201060@student.ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (WMFT) (time frame: at baseline and after intervention (4 weeks)). The study lists 3 primary outcomes in all. 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 NCT07243314, which also lists 5 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 21 Nov 2025.