The Effects of Accelerometer Triggered Functional Electrical Stimulation on Post-Stroke Hemiplegic Shoulder Subluxation

Study Overview
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Brief Summary
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Post stroke hemiplegia patient have shoulder subluxation in affected side. The investigators use functional electrical stimulation in posterior deltoid and supraspinatus for prevention and treatment. But the investigators hypothesis self triggered myoelectric stimulation system has more effective for shoulder subluxation. The purpose of this study is to compare post-stroke shoulder subluxation treatment FES and triggered FES.

Conditions
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Post-Stroke Hemiplegic Shoulder Subluxation

Intervention / Treatment
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* Procedure: Functional Electrical Stimulation (FES) treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Within 3months after stroke 1st stroke patients with hemiplegic shoulder subluxation which is measured above one finger breadth by physical examination Shoulder abduction strength is above P- grade (MMT) Male or female, ≥ 20 years of age Written informed consent has beed obtained Patients who understand purpose of this study and conform with intervention process Exclusion Criteria: Quadriplegia or double hemiplegia History of injury, surgery, etc. of U/E and upper chest area person who implanted metalic device(ex. pacemaker, vagus nerve stimulator) patients who have lower motor neuron lesion person who have difficulty using electrode due to skin problem such as skin ulcer or open wound who have seizure or epilepsy history Female who are pregnant

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: triggered FES<br> | Procedure: Functional Electrical Stimulation (FES) treatment<br>* This study is randomized controlled trial performed by Random permuted blocks. This study has 2 experimental groups and 1 control group. Both experimental group receive FES treatment of their posterior deltoid and supraspinatus. Experimental group 1(Acceleration group) uses Novastim CU FS1 once a day for 30 minutes during 3 weeks. During treatment patient give a maximal effort for shoulder abduction. Experimental group 2 (Convention group) receive cyclic FES treatment for reducing shoulder subluxation. All patients have evaluation pre-intervention, post-intervention, 3 weeks after intervention and 9 weeks after intervention including physical examination and x-ray.<br>|
| Active Comparator: conventional FES<br> | Procedure: Functional Electrical Stimulation (FES) treatment<br>* This study is randomized controlled trial performed by Random permuted blocks. This study has 2 experimental groups and 1 control group. Both experimental group receive FES treatment of their posterior deltoid and supraspinatus. Experimental group 1(Acceleration group) uses Novastim CU FS1 once a day for 30 minutes during 3 weeks. During treatment patient give a maximal effort for shoulder abduction. Experimental group 2 (Convention group) receive cyclic FES treatment for reducing shoulder subluxation. All patients have evaluation pre-intervention, post-intervention, 3 weeks after intervention and 9 weeks after intervention including physical examination and x-ray.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of vertical distance |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examination of affected side |  | 12 weeks | 
| Difference of joint distance of shoulder A-P radiograph |  | 12 weeks |