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Use of EMG to Assess Clinical Hypertonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472914
First Posted: May 14, 2007
Last Update Posted: May 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Terence Sanger, University of Southern California
  Purpose
A handheld surface electromyography device will be tested by clinicians on children with limb hypertonia, and inter-rater reliability will be assessed with and without the device.

Condition Intervention Phase
Cerebral Palsy Hypertonia Spasticity Dystonia Rigidity Device: portable surface electromyography Phase 1 Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Initial Assessment of the Use of Surface Electromyography as a Tool for Clinical Evaluation of Hypertonia in Children

Resource links provided by NLM:


Further study details as provided by Terence Sanger, University of Southern California:

Estimated Enrollment: 14
Study Start Date: January 2007
Study Completion Date: March 2007
Detailed Description:

Hypothesis:

Qualitative surface EMG measurement during passive movement will increase the inter-rater reliability of clinicians for diagnosis of spasticity and dystonia in children with hypertonia.

Specific Aims:

  1. Develop a handheld surface EMG device with auditory output that can be used similarly to a stethoscope to listen non-invasively to the activity of muscles.
  2. Provide clinicians at 5 different institutions with a device to test for 2 months in their own clinics.
  3. Bring all 5 clinicians to Stanford University for a single-day exercise in which each clinician will examine 10 children with hypertonia. Each clinician will rate the children without using the device, and then again with the device. Intra-class correlations and kappa statistics will be used to assess whether the use of the device leads to improved inter-rater reliability.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6-18
  • hypertonia in at least one limb due to spasticity

Exclusion Criteria:

  • any condition that would increase the risk of participation
  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): NCT00472914


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Terence D Sanger, Md, PhD Stanford University
  More Information

Responsible Party: Terence Sanger, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00472914     History of Changes
Other Study ID Numbers: EMG auditory
First Submitted: May 11, 2007
First Posted: May 14, 2007
Last Update Posted: May 23, 2014
Last Verified: May 2014

Keywords provided by Terence Sanger, University of Southern California:
Hypertonia
Childhood

Additional relevant MeSH terms:
Cerebral Palsy
Dystonia
Muscle Hypertonia
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Neuromuscular Manifestations