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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D-Printed Dynamic Splint Group | Experimental | will wear a 3D-printed dynamic splint at least 6 hours daily |
|
| Dynamic Splint Group | Active Comparator | will wear a conventional dynamic splint for at at least 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Printed splint | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | at baseline and after intervention (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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"). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zainab S alshammari, physical therapist | Contact | +966532984967 | 446201060@student.ksu.edu.sa | |
| Dr. Alaa M Albishi, Associate Professor | Contact | +966555090015 | aalbeshi@ksu.edu.sa |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sultan Bin Abdulaziz Humanitarian City | Riyadh | Riyadh Region | 13571 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31686529 | Result | 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. | |
| 22750961 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| conventional splint | Device | 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 |
|
| 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. | 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) | Each session (5 times per week) |
| 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. |
| 23949058 | Result | 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. |
| 34640564 | Result | 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. |
| 35533167 | Result | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |