Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472914
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2007-05-11
Brief Title:
Use of EMG to Assess Clinical Hypertonia
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Initial Assessment of the Use of Surface Electromyography as a Tool for Clinical Evaluation of Hypertonia in Children
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None