Trial record 1 of 171 for:    Hypertonia
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Use of EMG to Assess Clinical Hypertonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Terence Sanger, University of Southern California
ClinicalTrials.gov Identifier:
NCT00472914
First received: May 11, 2007
Last updated: May 21, 2014
Last verified: May 2014
  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 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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Terence Sanger, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00472914     History of Changes
Other Study ID Numbers: EMG auditory
Study First Received: May 11, 2007
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Hypertonia
Childhood

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

ClinicalTrials.gov processed this record on September 16, 2014