Post-Stroke Hemiplegic Shoulder SubluxationNCT02346851
The Effects of Accelerometer Triggered Functional Electrical Stimulation on Post-Stroke Hemiplegic Shoulder Subluxation
A study testing Functional Electrical Stimulation (FES) treatment in people with Post-Stroke Hemiplegic Shoulder Subluxation, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post-Stroke Hemiplegic Shoulder Subluxation
- What is being tested?
- Functional Electrical Stimulation (FES) treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Nov 2013to 16 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Functional Electrical Stimulation (FES) treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation (FES) treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| triggered FES | Experimental | Not described Receives: Procedure: Functional Electrical Stimulation (FES) treatment |
| conventional FES | Active comparator | Not described Receives: Procedure: Functional Electrical Stimulation (FES) treatment |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of vertical distance
Measured: 12 weeks
Secondary outcomes (2)
Physical examination of affected side
Measured: 12 weeks
Difference of joint distance of shoulder A-P radiograph
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study start12 Nov 2013
- Primary completion16 Sep 2015
- Study completion16 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post-Stroke Hemiplegic Shoulder SubluxationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346851
- Sponsor's protocol ID
- 4-2012-0602
- Status last verified
- Feb 2019
- First submitted
- 15 Jan 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9798835Chaco J, Wolf E. Subluxation of the glenohumeral joint in hemiplegia. Am J Phys Med. 1971 Jun;50(3):139-43. No abstract available.
PubMed 5579071Chan 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.
PubMed 19074684Embrey 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.
PubMed 20434604Tong 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.
PubMed 14686597Lau 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.
PubMed 17513111Koyuncu 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.
PubMed 20136474
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Accelerometer Triggered Functional Electrical Stimulation on Post-Stroke Hemiplegic Shoulder Subluxation
- ClinicalTrials.gov ID
- NCT02346851
- Acronym / sponsor ID
- 4-2012-0602
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Nov 2013
- Primary completion
- 16 Sep 2015 (actual)
- Study completion
- 16 Sep 2015 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| triggered FES | Experimental | Procedure: Functional Electrical Stimulation (FES) treatment |
| conventional FES | Active comparator | Procedure: Functional Electrical Stimulation (FES) treatment |
| control group | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical Stimulation (FES) treatmentThis 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. | Procedure or surgery | conventional FES, triggered FES |
Primary outcome
Difference of vertical distance
Time frame: 12 weeks
2 secondary outcomes
Physical examination of affected side
Time frame: 12 weeks
Difference of joint distance of shoulder A-P radiograph
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 9798835Ikai 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.
- Background: PubMed 5579071Chaco J, Wolf E. Subluxation of the glenohumeral joint in hemiplegia. Am J Phys Med. 1971 Jun;50(3):139-43. No abstract available.
- Background: PubMed 19074684Chan 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.
- Background: PubMed 20434604Embrey 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.
- Background: PubMed 14686597Tong 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.
- Background: PubMed 17513111Lau 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.
- Background: PubMed 20136474Koyuncu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation (FES) treatment in people with Post-Stroke Hemiplegic Shoulder Subluxation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of vertical distance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02346851, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.