Effect of 3D Printing Functional Hand Splints for Patients With Stroke
NCT ID: NCT06979934
Last Updated: 2025-05-20
Study Results
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Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-07-01
2022-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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3D printing splint group
3D printing splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day)
3D printing splint group
Wear 3D printing design splint for position for 60 minutes each time, plus 20 minutes of exercise which including:(1) Raise hands for 5 minutes, and bend and straighten the elbow for 5 minutes for proximal movement exercise;(2) Wear 3D printed design hand splint and change objects according to the ability of grasp, such as hold a cup, handle, eraser, pen, etc.
functional splint group
functional splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day)
functional splint group
Wear functional splint for position for 60 minutes each time, plus 20 minutes of exercise which including:(1) Raise hands for 5 minutes, and bend and straighten the elbow for 5 minutes for proximal movement exercise;(2) Grasp the holder according the grasp ability, such as hold a cup, handle, eraser, pen, etc.
Interventions
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3D printing splint group
Wear 3D printing design splint for position for 60 minutes each time, plus 20 minutes of exercise which including:(1) Raise hands for 5 minutes, and bend and straighten the elbow for 5 minutes for proximal movement exercise;(2) Wear 3D printed design hand splint and change objects according to the ability of grasp, such as hold a cup, handle, eraser, pen, etc.
functional splint group
Wear functional splint for position for 60 minutes each time, plus 20 minutes of exercise which including:(1) Raise hands for 5 minutes, and bend and straighten the elbow for 5 minutes for proximal movement exercise;(2) Grasp the holder according the grasp ability, such as hold a cup, handle, eraser, pen, etc.
Eligibility Criteria
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Inclusion Criteria
* Onset is more than three months;
* Able to understand activity instructions;
* Fugl-Meyer assessment 20-50 points
Exclusion Criteria
* 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.
20 Years
75 Years
ALL
No
Sponsors
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Taipei Medical University Shuang Ho Hospital
OTHER
Responsible Party
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Principal Investigators
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Hsinchieh Lee
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University, Taiwan, R.O.C.
Locations
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Shuang Ho Hospital, Taipei Medical University
Taipei, Taiwan, Taiwan
Countries
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References
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Other Identifiers
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TMU-JIRB N202104007
Identifier Type: -
Identifier Source: org_study_id
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