Use of EMG to Assess Clinical Hypertonia

Completed

• Conditions: Spasticity; Rigidity; Cerebral Palsy; Dystonia; Hypertonia

• Registration Number: NCT00472914
• Lead Sponsor: University of Southern California

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.

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 Timeline

• Study Start: 2007-01
• Study Completion: 2007-03
• Study First Submitted: 2007-05-11
• Study First Submitted QC: 2007-05-11
• Study First Posted: 2007-05-14
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-21
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States