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

NCT ID: NCT01139034

Last Updated: 2010-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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shoulder FES treatment

Group Type EXPERIMENTAL

Self-designed surface functional electrical stimulator

Intervention Type DEVICE

Use the self-designed surface functional electrical stimulator to improve the shoulder joint subluxation.

Interventions

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Self-designed surface functional electrical stimulator

Use the self-designed surface functional electrical stimulator to improve the shoulder joint subluxation.

Intervention Type DEVICE

Other Intervention Names

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Self-designed surface functional electrical stimulation

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Principal Investigators

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Jin-Shin Lai, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, NTUH, Taipei, Taiwan

Locations

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Department of Physical Medicine and Rehabilitation, NTUH

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jin-Shin Lai

Role: CONTACT

+886-2-23123456 ext. 66583

Facility Contacts

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Jin-Shin Lai

Role: primary

886-2-23123456 ext. 66583

Other Identifiers

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201002029D

Identifier Type: -

Identifier Source: org_study_id

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