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

National Taiwan University

Status and phase: Unknown; Phase 1

Conditions: Stroke

Treatments: Device: Self-designed surface functional electrical stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT01139034

201002029D

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

shoulder FES treatment

Experimental group

Treatment:

Device: Self-designed surface functional electrical stimulator