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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01139034
Collaborator
(none)
3
Enrollment
1
Location
1
Arm
12
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Self-designed surface functional electrical stimulator
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Rehabilitation Robot for Upper Limbs, Component Project 2: Hybrid of FES and Rehabilitation Robot for Treatment of Shoulder Subluxation
Study Start Date :
Mar 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2010
Anticipated Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: shoulder FES treatment

Device: Self-designed surface functional electrical stimulator
Use the self-designed surface functional electrical stimulator to improve the shoulder joint subluxation.
Other Names:
  • Self-designed surface functional electrical stimulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Upward migration index [1 year]

    Secondary Outcome Measures

    1. Acromiohumeral distance [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Physical Medicine and Rehabilitation, NTUH Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Jin-Shin Lai, MD, Department of Physical Medicine and Rehabilitation, NTUH, Taipei, Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01139034
    Other Study ID Numbers:
    • 201002029D
    First Posted:
    Jun 8, 2010
    Last Update Posted:
    Jun 22, 2010
    Last Verified:
    Jun 1, 2010

    Study Results

    No Results Posted as of Jun 22, 2010