Evaluating Functional Outcomes of 3D-Printed Splints in Post-Stroke Upper Limb Recovery

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Wolf Motor Function Test (WMFT) [Срок оценки: at baseline and after intervention (4 weeks)]
• Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE) [Срок оценки: at baseline and after intervention (4 weeks)]
• Box and Block Test (BBT) [Срок оценки: at baseline and after intervention (4 weeks)]

Вторичные конечные точки (3)

• Motor Activity Log (MAL) [Срок оценки: at baseline and after intervention (4 weeks)]
• Arabic Version of Stroke Impact Scale (SIS-16) [Срок оценки: at baseline and after intervention (4 weeks)]
• Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) [Срок оценки: Each session (5 times per week)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Саудовская Аравия · 1 центр

• Sultan Bin Abdulaziz Humanitarian City — Riyadh

Публикации

• 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. PMID 31686529
• 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. PMID 22750961
• 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. PMID 23949058
• 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. PMID 34640564
• 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. PMID 35533167

Идентификаторы

NCT: NCT07243314 · No.: 151-2025-IRB · Not found

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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