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

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.

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).

Inclusion Criteria:

1. Over 18 years old.
2. Chronic stroke
3. Upper limb hemiparalysis
4. Ability to understand and follow orders and able to provide informed consent (Mini-Mental State Exam (MMSE) > 24)
5. Upper-limb mild to moderate spasticity (Modified Ashworth Scale 1+ to 3 at the wrist).
6. Not participating in other clinical or research studies at the same time

Exclusion Criteria:

1. Had deficits in language or cognitive impairments that were likely to interfere with their cooperation in the study
2. Deformity or presented with severe upper-limb contractures
3. Inability to commit to the time requirement of the protocol.
4. Unilateral neglect