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

November 17, 2025 updated by: Zainab Saud Alshammari, King Saud University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dr. Alaa M Albishi, Associate Professor
  • Phone Number: +966555090015
  • Email: aalbeshi@ksu.edu.sa

Study Locations

  • Saudi Arabia
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabia, 13571
        • Sultan Bin Abdulaziz Humanitarian City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Over 18 years old.
  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:

  1. Had deficits in language or cognitive impairments that were likely to interfere with their cooperation in the study
  2. Deformity or presented with severe upper-limb contractures
  3. Inability to commit to the time requirement of the protocol.
  4. Unilateral neglect

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D-Printed Dynamic Splint Group
will wear a 3D-printed dynamic splint at least 6 hours daily
Device: 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
Active Comparator: Dynamic Splint Group
will wear a conventional dynamic splint for at at least 6 hours
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline and after intervention (4 weeks)
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.
at baseline and after intervention (4 weeks)
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.
at baseline and after intervention (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Activity Log (MAL)
Time Frame: at baseline and after intervention (4 weeks)
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").
at baseline and after intervention (4 weeks)
Arabic Version of Stroke Impact Scale (SIS-16)
Time Frame: at baseline and after intervention (4 weeks)
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)
Time Frame: Each session (5 times per week)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.: 151-2025-IRB
  • Not found (Other Identifier: Not found)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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