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

May 11, 2007
May 21, 2014
January 2007
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Complete list of historical versions of study NCT00472914 on ClinicalTrials.gov Archive Site
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Use of EMG to Assess Clinical Hypertonia
Initial Assessment of the Use of Surface Electromyography as a Tool for Clinical Evaluation of Hypertonia in Children

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.

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.
Observational
Time Perspective: Prospective
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  • Cerebral Palsy
  • Hypertonia
  • Spasticity
  • Dystonia
  • Rigidity
Device: portable surface electromyography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
March 2007
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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
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00472914
EMG auditory
No
Terence Sanger, University of Southern California
University of Southern California
Not Provided
Principal Investigator: Terence D Sanger, Md, PhD Stanford University
University of Southern California
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP