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NCT07243314Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
17 Nov 2025
Start date
Nov 2025
Primary completion date
30 Sept 2027
Lead sponsor
King Saud University
Diseases
Stroke
NCT number
NCT07243314

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From Nov 2025 to the primary completion date, 30 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sultan Bin Abdulaziz Humanitarian City
Coordinator of this site? Confirm its status
RiyadhSaudi ArabiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.