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

Post-Stroke Hemiplegic Shoulder Subluxation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346851
• Other study ID #: 4-2012-0602
• Status: Completed
• Phase: N/A
• Start date: November 12, 2013
• Est. completion date: September 16, 2015

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 16, 2015
• Est. primary completion date: September 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-Stroke Hemiplegic Shoulder Subluxation
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

Chaco J, Wolf E. Subluxation of the glenohumeral joint in hemiplegia. Am J Phys Med. 1971 Jun;50(3):139-43. — View 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. — View 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. — View 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. — View Citation

Koyuncu E, Nakipoglu-Yüzer 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. — View 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. Epub 2007 May 21. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of vertical distance		12 weeks
Secondary	Physical examination of affected side		12 weeks
Secondary	Difference of joint distance of shoulder A-P radiograph		12 weeks