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

NCT07243314 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-21

No results posted yet for this study

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.

Conditions

  • Stroke
  • Stroke Rehabilitation
  • Hemiparesis of the Upper Limb Following Stroke

Interventions

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

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

Sponsors & Collaborators

  • King Saud University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Saudi Arabia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07243314 on ClinicalTrials.gov