Stroke
Conditions
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.
Interventions
BEHAVIORAL3D 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.
BEHAVIORALfunctional 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.
Sponsors
Taipei Medical University Shuang Ho Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment-upper extremity | Change from Baseline at 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynanometer | Change from Baseline at 8 weeks | 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. |
| Range of motion of upper limb joints | Change from Baseline at 8 weeks | Passive movement angle of elbow joint, wrist joint and thumb, finger metacarpophalangeal joint.The unit of measure is degree. |
| Disabilities of The Arm, Shoulder And Hand Questionnaire | Change from Baseline at 8 weeks | 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. |
| Electromyography | Change from Baseline at 8 weeks | 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. |
| Satisfaction questionnaire | Every training session, total sessions continued to 8 weeks | 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. |
| Wear performance record | Every training session, total sessions continued to 8 weeks | The wear and exercise times were recorded every day. The unit of measure is number of times. |
| Side effects record | Every training session, total sessions continued to 8 weeks | 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. |
Countries
Taiwan
Outcome results
None listed