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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01139034
First received: June 7, 2010
Last updated: June 20, 2010
Last verified: June 2010
History of Changes

June 7, 2010
June 20, 2010
March 2010
December 2010   (final data collection date for primary outcome measure)
Upward migration index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01139034 on ClinicalTrials.gov Archive Site
Acromiohumeral distance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pilot Study of Shoulder Subluxation Treatment by Using the Self-Designed Surface Functional Electrical Stimulator
Rehabilitation Robot for Upper Limbs, Component Project 2: Hybrid of FES and Rehabilitation Robot for Treatment of Shoulder Subluxation

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

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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Stroke
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
Experimental: shoulder FES treatment
Intervention: Device: Self-designed surface functional electrical stimulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3
March 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
25 Years to 65 Years
No
Contact: Jin-Shin Lai +886-2-23123456 ext 66583 jslai@ntu.edu.tw
Taiwan
 
NCT01139034
201002029D
No
Jin-Shin Lai, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Jin-Shin Lai, MD Department of Physical Medicine and Rehabilitation, NTUH, Taipei, Taiwan
National Taiwan University Hospital
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP