A Pilot Study of Shoulder Subluxation Treatment by Using the Self-Designed Surface Functional Electrical Stimulator

Phase 1

• Conditions: Stroke
• Interventions: Device: Self-designed surface functional electrical stimulator

• Registration Number: NCT01139034
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The purpose of this study is to investigate the effects of the self-designed surface functional electrical stimulator on shoulder joint subluxation for stroke patients

Detailed Description

Functional electrical stimulation (FES) is a common and effective therapeutic approach for clinical treatments of shoulder subluxation. By applying low-frequency electrical stimulation to the target muscle groups, improvements may be observed in terms of muscle strength, subluxation, and passive humeral lateral rotation of the shoulder joint. In order to overcome issues regarding the integration of an FES and a rehabilitation robot, group members have designed a customized FES system approved by medical safety regulations. Despite sharing identical specifications with commercial models, the approved 2-channel FES system provides better integrity and control when working with the upper extremity rehabilitation robot. In this study, three patients with unilateral shoulder subluxation will be recruited. Limited shoulder x-ray photos shall be taken before, during, and after the FES shoulder subluxation treatment for studying the effects.

Study Timeline

• Study Start: 2010-03
• Status Verified: 2010-06
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-08
• Last Update Submitted: 2010-06-20
• Last Update Posted: 2010-06-22
• Primary Completion: 2010-12
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• stroke (1-3 months)
• Brunnstrom Stage I-III
• single, unilateral

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Exclusion Criteria

• aphasic
• shoulder impairment
• severe osteoporosis
• cardiac arrhythmias or having a pacemaker implanted
• abnormal cutaneous sensation at the target areas

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
shoulder FES treatment	Self-designed surface functional electrical stimulator	-

Primary Outcome Measures

Name	Time	Method
Upward migration index	1 year

Secondary Outcome Measures

Name	Time	Method
Acromiohumeral distance	1 year

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, NTUH; 🇨🇳 Taipei, Taiwan