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

Not Applicable

Completed

• Conditions: Post-Stroke Hemiplegic Shoulder Subluxation
• Interventions: Procedure: Functional Electrical Stimulation (FES) treatment

• Registration Number: NCT02346851
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-12
• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-27
• Primary Completion: 2015-09-16
• Study Completion: 2015-09-16
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Within 3months after stroke
2. 1st stroke patients with hemiplegic shoulder subluxation which is measured above one finger breadth by physical examination
3. Shoulder abduction strength is above P- grade (MMT)
4. Male or female, ≥ 20 years of age
5. Written informed consent has beed obtained
6. Patients who understand purpose of this study and conform with intervention process

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Exclusion Criteria

1. Quadriplegia or double hemiplegia
2. History of injury, surgery, etc. of U/E and upper chest area
3. person who implanted metalic device(ex. pacemaker, vagus nerve stimulator)
4. patients who have lower motor neuron lesion
5. person who have difficulty using electrode due to skin problem such as skin ulcer or open wound
6. who have seizure or epilepsy history
7. Female who are pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional FES	Functional Electrical Stimulation (FES) treatment	-
triggered FES	Functional Electrical Stimulation (FES) treatment	-

Primary Outcome Measures

Name	Time	Method
Difference of vertical distance	12 weeks

Secondary Outcome Measures

Name	Time	Method
Physical examination of affected side	12 weeks
Difference of joint distance of shoulder A-P radiograph	12 weeks

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of