Use of EMG to Assess Clinical Hypertonia

NCT ID: NCT00472914

Last Updated: 2014-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy Hypertonia Spasticity Dystonia Rigidity

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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portable surface electromyography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Terence Sanger

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terence D Sanger, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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EMG auditory

Identifier Type: -

Identifier Source: org_study_id

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