An interventional study of 3D Printed splint and conventional splint in Stroke, Stroke Rehabilitation and Hemiparesis of the Upper Limb Following Stroke, sponsored by King Saud University. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by King Saud University · Not applicable, Interventional, and Treatment
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).
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →King Saud University is the lead sponsor of 164 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
will wear a 3D-printed dynamic splint at least 6 hours daily
Device: 3D Printed splint
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 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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline and after intervention (4 weeks)
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").
Time frame: 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.
Time frame: 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)
Time frame: Each session (5 times per week)
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
King Saud University