NCT00504049

Brief Summary

Several methods exist to evaluate motor function in the child with cerebral palsy and are used to assess the outcome of a clinical intervention. However, these scales are not directed towards measuring the changes in muscle activity patterns that can result from the intervention. For example, there are classification scales aimed at measuring motor function and functional abilities, and indices of gait function. These scores, while providing a way to quantify function and mechanics, do not directly measure muscle activation characteristics. Therefore, these tests may be insensitive to how the intervention has directly affected muscle function, which is usually the focus of the intervention (i.e. botulinum toxin, functional electrical stimulation, dorsal rhizotomy). Muscle biopsies and motor evoked potentials can provide information about the muscle activation characteristics, however, they are invasive and there are concerns about using these techniques on the pediatric population and/or the practicality of clinical implementation, especially since they do not provide insight into how the muscle behaves during a functional task. One method that can be used to provide insight into muscle activity in a non-invasive and clinically meaningful manner is the use of surface electromyography (sEMG). Surface EMG is typically a routine part of clinical assessment and the evaluation of motor impairment in CP. However, the analysis of the data has been limited in most cases to examination of signal amplitude or differences in muscle onset and offset timing. The long-term goal of this research is to develop an analysis method for sEMG that can be used during functional tasks for treatment planning, diagnostic, assessment purposes in CP. This is to be accomplished through the use of the continuous wavelet transform (CWT). By developing an assessment method based on muscle activity, it is believed that a clinically viable measurement tool can be devised that will provide a level of insight into the effects of an intervention on muscle pathophysiology that is not currently available. The first step in progressing towards this long-term goal is to determine the variability and range of expected time-frequency patterns that can be expressed in a given population (i.e., cerebral palsy) during the execution of a meaningful task (gait), and relate the time-frequency information back to more standard assessments

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 22, 2010

Status Verified

January 1, 2009

First QC Date

July 17, 2007

Last Update Submit

July 21, 2010

Conditions

Keywords

Cerebral PalsyElectromyographyWavelet Analysis

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with spastic, diplegic cerebral palsy

You may qualify if:

  • A diagnosis of spastic diplegic CP
  • Must be ambulatory without the use of orthotics
  • Between a GMFCS Level I and Level III
  • Between the ages of 7 and 13 years
  • Cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature \> 40 degrees)
  • Seizure-free or seizure controlled
  • Has visuoperceptual skills and cognitive/communication skills sufficient to follow multiple step commands and to attend to tasks associated with data collection
  • Must be greater than 1 year post-surgery to the lower extremities
  • Must be greater then 6 months botulinum toxin injection
  • Passive range of motion in lower extremity joints must be greater than 10 degrees of flexion contracture at the hips as measured by the Thomas Test, at least 20 degrees of hip abduction bilaterally, less than 5 degrees of knee flexion contracture, popliteal angle less than 45 degrees, and at least 0 degrees of ankle dorsiflexion with the knee extended while the foot is in varus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Richard T Lauer, PhD

    Shriners Hospitals for Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

March 1, 2007

Study Completion

March 1, 2009

Last Updated

July 22, 2010

Record last verified: 2009-01

Locations