An interventional study of 3D printing splint group and functional splint group in Stroke, sponsored by Taipei Medical University Shuang Ho Hospital. Withdrawn at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
3D printing splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day)
Behavioral: 3D printing splint group
functional splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day)
Behavioral: functional 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.
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.
Fugl-Meyer Assessment-upper extremity
The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66.The unit of measure is score.
Time frame: Change from Baseline at 8 weeks
Electromyography
Record the maximum voluntary contraction (maximal voluntary contraction; MVC) of the wrist extensor muscles, total extensor muscles, and flexor muscles.The unit of measure is motor unit.
Time frame: Change from Baseline at 8 weeks
Dynanometer
The grip dynamometer was used to measure the maximum isometric strength of the hand and forearm muscles. The mean score of 3 trials was calculated. For this measurement, the elbow was placed at 90° and the forearm was placed in mid-position.The unit of measure is kilograms.
Time frame: Change from Baseline at 8 weeks
Range of motion of upper limb joints
Passive movement angle of elbow joint, wrist joint and thumb, finger metacarpophalangeal joint.The unit of measure is degree.
Time frame: Change from Baseline at 8 weeks
Disabilities of The Arm, Shoulder And Hand Questionnaire
a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. We used the subtest of Activity capacity, severity of illness.The unit of measure is score.
Time frame: Change from Baseline at 8 weeks
Side effects record
The number of side effects after intervention (such as soreness, pain, motion vertigo, injury, etc.) were recorded every day. The unit of measure is number of times.
Time frame: Every training session, total sessions continued to 8 weeks
Satisfaction questionnaire
The questionnaire is a subjective self-filling scale using a hand brace, with 5-level scores (strongly agree to strongly disagree), including aesthetics, complexity, weight, resistance, comfort, ease of wear, etc.The unit of measure is score.
Time frame: Every training session, total sessions continued to 8 weeks
Wear performance record
The wear and exercise times were recorded every day. The unit of measure is number of times.
Time frame: Every training session, total sessions continued to 8 weeks
Plan to share: No
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Taipei Medical University Shuang Ho Hospital