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

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Yonsei University

Status

Completed

Conditions

Post-Stroke Hemiplegic Shoulder Subluxation

Treatments

Procedure: Functional Electrical Stimulation (FES) treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02346851
4-2012-0602

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

76 participants in 3 patient groups

triggered FES
Experimental group
Treatment:
Procedure: Functional Electrical Stimulation (FES) treatment
conventional FES
Active Comparator group
Treatment:
Procedure: Functional Electrical Stimulation (FES) treatment
control group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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