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

February 25, 2019 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: triggered FES
Procedure: Functional Electrical Stimulation (FES) treatment
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.
Active Comparator: conventional FES
Procedure: Functional Electrical Stimulation (FES) treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference of vertical distance
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 12, 2013

Primary Completion (Actual)

September 16, 2015

Study Completion (Actual)

September 16, 2015

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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