Evaluating Functional Outcomes of 3D-Printed Splints in Post-Stroke Upper Limb Recovery (NCT07243314) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating Functional Outcomes of 3D-Printed Splints in Post-Stroke Upper Limb Recovery
Saudi Arabia100 participantsStarted 2025-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wolf Motor Function Test (WMFT)
Timeframe: at baseline and after intervention (4 weeks)
2
Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
Timeframe: at baseline and after intervention (4 weeks)
3
Box and Block Test (BBT)
Timeframe: at baseline and after intervention (4 weeks)