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

NCT07243314 | Not Yet Recruiting DMC

• 2 other identifiers: No.: 151-2025-IRBNot found
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Stroke Rehabilitation; Hemiparesis of the Upper Limb Following Stroke

Keywords

stroke; Ischemic Stroke; Hemorrhagic Stroke; Hemiparesis; Splint; Dynamic Splint; Three-Dimensional Printing; 3D-Printed Splint; Orthosis; Task-Oriented; Traditional Dynamic Splint; Motor Function

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (3)

• Motor Activity Log (MAL)

  at baseline and after intervention (4 weeks)

• Arabic Version of Stroke Impact Scale (SIS-16)

  at baseline and after intervention (4 weeks)

• Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)

  Each session (5 times per week)

Study Arms (2)

3D-Printed Dynamic Splint Group

EXPERIMENTAL

will wear a 3D-printed dynamic splint at least 6 hours daily

Device: 3D Printed splint

Dynamic Splint Group

ACTIVE COMPARATOR

will wear a conventional dynamic splint for at at least 6 hours

Device: conventional splint

Interventions

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

3D-Printed Dynamic Splint Group

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

Dynamic Splint Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

Sultan Bin Abdulaziz Humanitarian City

Riyadh, Riyadh Region, 13571, Saudi Arabia

Location

Related Publications (5)

• 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 RESULT

• 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 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.

  PMID: 23949058 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.

  PMID: 34640564 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.

  PMID: 35533167 RESULT

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

zainab S alshammari, physical therapist

CONTACT

+966532984967; 446201060@student.ksu.edu.sa

Dr. Alaa M Albishi, Associate Professor

CONTACT

+966555090015; aalbeshi@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

SA (1)