Clinical trial NCT06979934: Effect of 3D Printing Functional Hand Splints for Patients With Stroke
Official title: The Effect of 3D Printing Functional Splints on Hand Function for Patients With Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to evaluate the effect of 3D printing functional splints on hand function for patients with stroke.Twenty stroke patients with moderate motor deficits were recruited and randomized into experimental (3D printing splint) or control (functional splint) groups for 8 weeks of treatment.The performance was assessed by a blinded assessor for two times including motor, function, and feasibility.Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.

Detailed description: Background: Spasticity is an important factor limiting independency and activity of daily living for post-stroke patients. Splinting has been proved to be successful treatment for spasticity.3D printing technology was used to construct personalized, complicated orthosis, and one piece to reduce assembly time. The evidence most are product development, but few of study investigate the effectiveness.

Aim: To evaluate the effect of 3D printing functional splints on hand function for patients with stroke.

Methods: Twenty stroke patients with moderate motor deficits were recruited and randomized into experimental (3D printing splint) or control (functional splint) groups for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day). The performance was assessed by a blinded assessor for two times included Fugl-Meyer Assessment-Upper Limb section(FMA-UE), Electromyography (EMG), Grip dynamometer, Passive Range of motion (PROM) at upper extremity, Muscle tone at upper extremity, and Disability of the arm, shoulder and hand questionnaire(DASH). The splint wearing performance and Satisfaction were recorded. Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.

Eligibility criteria: Inclusion Criteria:

* Cerebral stroke, patients with unilateral hemiplegia
* Onset is more than three months;
* Able to understand activity instructions;
* Fugl-Meyer assessment 20-50 points

Exclusion Criteria:

* Age over 75 years and under 20 years old;
* Other medical diseases that affect the execution program
* Modified Ashworth Scale of Wrist and hand greater than 2 Points
* Deformed elbow, wrist and hand joints
* Treated with botulinum toxin on the upper limbs of the affected side.

Primary outcomes:
measure: Fugl-Meyer Assessment-upper extremity
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Electromyography
timeFrame: Change from Baseline at 8 weeks
measure: Dynanometer
timeFrame: Change from Baseline at 8 weeks
measure: Range of motion of upper limb joints
timeFrame: Change from Baseline at 8 weeks
measure: Disabilities of The Arm, Shoulder And Hand Questionnaire
timeFrame: Change from Baseline at 8 weeks
measure: Side effects record
timeFrame: Every training session, total sessions continued to 8 weeks
measure: Satisfaction questionnaire
timeFrame: Every training session, total sessions continued to 8 weeks
measure: Wear performance record
timeFrame: Every training session, total sessions continued to 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shuang Ho Hospital, Taipei Medical University
Study officials:
affiliation: Taipei Medical University, Taiwan, R.O.C.
name: Hsinchieh Lee
role: PRINCIPAL_INVESTIGATOR
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