Effect of 3D Printing Functional Hand Splints for Patients With Stroke

Taipei Medical University

Status: Withdrawn

Conditions: Stroke

Treatments: Behavioral: functional splint group; Behavioral: 3D printing splint group

Study type: Interventional

Funder types: Other

Identifiers

NCT06979934

TMU-JIRB N202104007

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

3D printing splint group

Experimental group

Description:

3D printing splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day)

Treatment:

Behavioral: 3D printing splint group

functional splint group

Active Comparator group

Description:

functional splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day)

Treatment:

Behavioral: functional splint group