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NCT Number: NCT07243314

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis of the Upper Limb Following Stroke Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Rehabilitation Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan Bin Abdulaziz Humanitarian City

Riyadh, Riyadh Region, 13571, Saudi Arabia

Location contact

Arwa H Aloumi

CONTACT

[email protected]

+966556746668

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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").

  2. 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.

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Alaa M Albishi, Associate Professor

CONTACT

[email protected]

+966555090015

zainab S alshammari, physical therapist

CONTACT

[email protected]

+966532984967

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Acronym: 3D-splint

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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