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
  Purpose

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
Stroke
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

Resource links provided by NLM:


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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
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

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

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

Additional relevant MeSH terms:
Stroke
Dislocations
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014