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Use of EMG to Assess Clinical Hypertonia

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT00472914
Collaborator
(none)
14
Enrollment
1
Location
1.9
Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: portable surface electromyography

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.

Study Design

Study Type:
Observational
Time Perspective:
Prospective
Official Title:
Initial Assessment of the Use of Surface Electromyography as a Tool for Clinical Evaluation of Hypertonia in Children
Study Start Date :
Jan 1, 2007
Actual Study Completion Date :
Mar 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94305

    Sponsors and Collaborators

    • University of Southern California

    Investigators

    • Principal Investigator: Terence D Sanger, Md, PhD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Terence Sanger, Associate Professor, University of Southern California
    ClinicalTrials.gov Identifier:
    NCT00472914
    Other Study ID Numbers:
    • EMG auditory
    First Posted:
    May 14, 2007
    Last Update Posted:
    May 23, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Terence Sanger, Associate Professor, University of Southern California
    Hypertonia
    Childhood
    Additional relevant MeSH terms:
    Cerebral Palsy
    Dystonia
    Muscle Hypertonia

    Study Results

    No Results Posted as of May 23, 2014