Completed

NCT Number: NCT02346851

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

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.

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Key information

Conditions

Post-Stroke Hemiplegic Shoulder Subluxation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Electrical Stimulation (FES) treatment

Procedure

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 outcomes

Difference of vertical distance

Time frame: 12 weeks

Secondary outcomes

Physical examination of affected side

Time frame: 12 weeks
Difference of joint distance of shoulder A-P radiograph

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jan 27, 2015
Registry last updated: Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.