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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02346851
Enrollment
76
Registered
2015-01-27
Start date
2013-11-12
Completion date
2015-09-16
Last updated
2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Stroke Hemiplegic Shoulder Subluxation

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.

Interventions

PROCEDUREFunctional 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Difference of vertical distance12 weeks

Secondary

MeasureTime frame
Physical examination of affected side12 weeks
Difference of joint distance of shoulder A-P radiograph12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026