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

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ClinicalTrials.gov Identifier: NCT01139034
Recruitment Status : Unknown
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 8, 2010
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:

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
Stroke 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  (Clinical Trial)
Estimated Enrollment : 3 participants
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 : March 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

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 Name: Self-designed surface functional electrical stimulation


Outcome Measures

Primary Outcome Measures :
  1. Upward migration index [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Acromiohumeral distance [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139034


Contacts
Contact: Jin-Shin Lai +886-2-23123456 ext 66583 jslai@ntu.edu.tw

Locations
Taiwan
Department of Physical Medicine and Rehabilitation, NTUH Recruiting
Taipei, Taiwan
Contact: Jin-Shin Lai    886-2-23123456 ext 66583    jslai@ntu.edu.tw   
Principal Investigator: Jin-Shin Lai, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jin-Shin Lai, MD Department of Physical Medicine and Rehabilitation, NTUH, Taipei, Taiwan
More Information

Responsible Party: Jin-Shin Lai, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01139034     History of Changes
Other Study ID Numbers: 201002029D
First Posted: June 8, 2010    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010