Evaluating Functional Outcomes of 3D-Printed Splints in Post-Stroke Upper Limb Recovery
NCT ID: NCT07243314
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-11-30
2027-09-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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3D-Printed Dynamic Splint Group
will wear a 3D-printed dynamic splint at least 6 hours daily
3D Printed splint
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
Dynamic Splint Group
will wear a conventional dynamic splint for at at least 6 hours
conventional splint
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
Interventions
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3D Printed splint
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 splint
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
Eligibility Criteria
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Inclusion Criteria
2. Chronic stroke
3. Upper limb hemiparalysis
4. Ability to understand and follow orders and able to provide informed consent (Mini-Mental State Exam (MMSE) \> 24)
5. Upper-limb mild to moderate spasticity (Modified Ashworth Scale 1+ to 3 at the wrist).
6. Not participating in other clinical or research studies at the same time
Exclusion Criteria
2. Deformity or presented with severe upper-limb contractures
3. Inability to commit to the time requirement of the protocol.
4. Unilateral neglect
18 Years
ALL
No
Sponsors
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King Saud University
OTHER
Responsible Party
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Zainab Saud Alshammari
Physical therapist
Locations
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Sultan Bin Abdulaziz Humanitarian City
Riyadh, Riyadh Region, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Jeon 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.
Andringa 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.
Yang 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.
Chen 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.
Other Identifiers
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Not found
Identifier Type: OTHER
Identifier Source: secondary_id
No.: 151-2025-IRB
Identifier Type: -
Identifier Source: org_study_id
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