Clinical trial NCT02346851: The Effects of Accelerometer Triggered Functional Electrical Stimulation on Post-Stroke Hemiplegic Shoulder Subluxation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Stroke Hemiplegic Shoulder Subluxation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference of vertical distance
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical examination of affected side
timeFrame: 12 weeks
measure: Difference of joint distance of shoulder A-P radiograph
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.