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

Primary Purpose

Post-Stroke Hemiplegic Shoulder Subluxation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Functional Electrical Stimulation (FES) treatment
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Stroke Hemiplegic Shoulder Subluxation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

triggered FES

conventional FES

control group

Arm Description

Outcomes

Primary Outcome Measures

Difference of vertical distance

Secondary Outcome Measures

Physical examination of affected side
Difference of joint distance of shoulder A-P radiograph

Full Information

First Posted
January 15, 2015
Last Updated
February 25, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02346851
Brief Title
The Effects of Accelerometer Triggered Functional Electrical Stimulation on Post-Stroke Hemiplegic Shoulder Subluxation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 12, 2013 (undefined)
Primary Completion Date
September 16, 2015 (Actual)
Study Completion Date
September 16, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Stroke Hemiplegic Shoulder Subluxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
triggered FES
Arm Type
Experimental
Arm Title
conventional FES
Arm Type
Active Comparator
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Functional Electrical Stimulation (FES) treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference of vertical distance
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Physical examination of affected side
Time Frame
12 weeks
Title
Difference of joint distance of shoulder A-P radiograph
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
9798835
Citation
Ikai T, Tei K, Yoshida K, Miyano S, Yonemoto K. Evaluation and treatment of shoulder subluxation in hemiplegia: relationship between subluxation and pain. Am J Phys Med Rehabil. 1998 Sep-Oct;77(5):421-6. doi: 10.1097/00002060-199809000-00012.
Results Reference
background
PubMed Identifier
5579071
Citation
Chaco J, Wolf E. Subluxation of the glenohumeral joint in hemiplegia. Am J Phys Med. 1971 Jun;50(3):139-43. No abstract available.
Results Reference
background
PubMed Identifier
19074684
Citation
Chan MK, Tong RK, Chung KY. Bilateral upper limb training with functional electric stimulation in patients with chronic stroke. Neurorehabil Neural Repair. 2009 May;23(4):357-65. doi: 10.1177/1545968308326428. Epub 2008 Dec 12.
Results Reference
background
PubMed Identifier
20434604
Citation
Embrey DG, Holtz SL, Alon G, Brandsma BA, McCoy SW. Functional electrical stimulation to dorsiflexors and plantar flexors during gait to improve walking in adults with chronic hemiplegia. Arch Phys Med Rehabil. 2010 May;91(5):687-96. doi: 10.1016/j.apmr.2009.12.024.
Results Reference
background
PubMed Identifier
14686597
Citation
Tong KY, Mak AF, Ip WY. Command control for functional electrical stimulation hand grasp systems using miniature accelerometers and gyroscopes. Med Biol Eng Comput. 2003 Nov;41(6):710-7. doi: 10.1007/BF02349979.
Results Reference
background
PubMed Identifier
17513111
Citation
Lau H, Tong K. The reliability of using accelerometer and gyroscope for gait event identification on persons with dropped foot. Gait Posture. 2008 Feb;27(2):248-57. doi: 10.1016/j.gaitpost.2007.03.018. Epub 2007 May 21.
Results Reference
background
PubMed Identifier
20136474
Citation
Koyuncu E, Nakipoglu-Yuzer GF, Dogan A, Ozgirgin N. The effectiveness of functional electrical stimulation for the treatment of shoulder subluxation and shoulder pain in hemiplegic patients: A randomized controlled trial. Disabil Rehabil. 2010;32(7):560-6. doi: 10.3109/09638280903183811.
Results Reference
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The Effects of Accelerometer Triggered Functional Electrical Stimulation on Post-Stroke Hemiplegic Shoulder Subluxation

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