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Use of EMG to Assess Clinical Hypertonia

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00472914
First received: May 11, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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:

U.S. FDA Resources

Further study details as provided by Stanford University:

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
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
Stanford University
Investigators
Principal Investigator: Terence D Sanger, Md, PhD Stanford University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00472914     History of Changes
Other Study ID Numbers: EMG auditory
Study First Received: May 11, 2007
Last Updated: May 11, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Hypertonia
Childhood

Additional relevant MeSH terms:
Cerebral Palsy
Dystonia
Dystonic Disorders
Muscle Hypertonia
Muscle Rigidity
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Movement Disorders
Neuromuscular Manifestations
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 21, 2013