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

June 20, 2010 updated by: National Taiwan University Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Upward migration index
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Acromiohumeral distance
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 8, 2010

Study Record Updates

Last Update Posted (Estimate)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 20, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 201002029D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Self-designed surface functional electrical stimulator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe