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

King Saud University

Status: Not yet enrolling

Conditions: Hemiparesis of the Upper Limb Following Stroke; Stroke; Stroke Rehabilitation

Treatments: Device: 3D Printed splint; Device: conventional splint

Study type: Interventional

Funder types: Other

Identifiers

NCT07243314

No.: 151-2025-IRB

Not found (Other Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

3D-Printed Dynamic Splint Group

Experimental group

Description:

will wear a 3D-printed dynamic splint at least 6 hours daily

Treatment:

Device: 3D Printed splint

Dynamic Splint Group

Active Comparator group

Description:

will wear a conventional dynamic splint for at at least 6 hours

Treatment:

Device: conventional splint