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
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
First received: June 7, 2010
Last updated: June 20, 2010
Last verified: June 2010
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 Intervention Phase
Device: Self-designed surface functional electrical stimulator
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Upward migration index [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acromiohumeral distance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 3
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139034

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

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

No publications provided

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 
Study First Received: June 7, 2010
Last Updated: June 20, 2010
Health Authority: Taiwan: Department of Health

ClinicalTrials.gov processed this record on February 11, 2016