Use of EMG to Assess Clinical Hypertonia

Cerebral Palsy Clinical Trial

Official title:

Initial Assessment of the Use of Surface Electromyography as a Tool for Clinical Evaluation of Hypertonia in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472914
• Other study ID #: EMG auditory
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 11, 2007
• Last updated: May 21, 2014
• Start date: January 2007
• Est. completion date: March 2007

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Palsy
• Dystonia
• Hypertonia
• Muscle Hypertonia
• Rigidity
• Spasticity

Intervention

Device:
• portable surface electromyography

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States,