Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699554
• Other study ID #: 44170
• Secondary ID: 1R01NS091056-01A
• Status: Completed
• Start date: September 2015
• Est. completion date: September 2020

Study information

• Verified date: May 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Impaired neuromuscular control hinders movement for individuals with cerebral palsy and other neurological disorders. In this research, the investigators are developing new tools to quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one of the most common treatments, orthopaedic surgery. The results from this research will empower clinicians to identify patient-specific factors that contribute to impaired movement and improve treatment and quality of life.

Description:

The long-term goals of this research are to quantify patient-specific changes in neuromuscular control in order to optimize treatment planning and improve mobility for individuals with cerebral palsy (CP). As a first step, the aims of this proposal are to evaluate neuromuscular control before and after one of the most common treatments for individuals with CP, orthopaedic surgery. The investigators will evaluate if patient-specific measures of neuromuscular control, based upon the framework of muscle synergies, can predict improvements in walking ability after surgery. Further, investigators will determine whether neuromuscular control changes after surgery and if these changes contribute to improvements in movement. To achieve these goal the investigators will implement and test new tools to quantify neuromuscular control which integrate clinical gait analysis and two computational techniques: synergy analysis and dynamic musculoskeletal simulation. This research will provide the foundation to use measures of altered neuromuscular control to inform treatment planning, develop alternative treatments, and improve mobility in CP and other neurologic disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diplegic cerebral palsy
• Mild or Moderate Impairment, Gross Motor Function Classification System (GMFCS) Levels I-III
• Will receive follow-up care and physical therapy within the Gillette Children's Specialty Healthcare system

Exclusion Criteria:

• Botulinum toxin injections, baclofen, or other similar treatments in the 3 months prior to pre-operative gait analysis

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• Single-event multilevel surgery

Locations

Country	Name	City	State
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Gillette Children's Specialty Healthcare, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery	The Walk Dynamic Motor Control Index (Walk DMC) is a specific measurement calculated from electromyography during gait using nonnegative matrix factorization. A value of 100 indicates complexity of neuromuscular control similar to typically-developing peers and each 10 point deviation represents one standard deviation from typically-developing peers. Thus, a value of 80 would indicate that an individual's muscle coordination during gait is two standard deviations below the complexity of unimpaired individuals.	6-months after individual's orthopaedic surgery
Primary	Change in Walk Dynamic Motor Control Index 1-year After Orthopaedic Surgery	The Walk Dynamic Motor Control Index (Walk DMC) is a specific measurement calculated from electromyography during gait using nonnegative matrix factorization. A value of 100 indicates complexity of neuromuscular control similar to typically-developing peers and each 10 point deviation represents one standard deviation from typically-developing peers. Thus, a value of 80 would indicate that an individual's muscle coordination during gait is two standard deviations below the complexity of unimpaired individuals.	1-year after individual's orthopaedic surgery
Secondary	Change in Gait Deviation Index 6-months After Orthopaedic Surgery	The Gait Deviation Index is a specific measurement which uses kinematics measured from instrumented gait analysis to compare an individual's gait pattern to typically-developing controls. A value of 100 indicates kinematics similar to unimpaired individuals while each 10 point deviation represents one standard deviation from unimpaired gait. Thus, a value of 80 would indicate that an individual's gait kinematics are on average two standard deviations from unimpaired gait.	6-months after individual's orthopaedic surgery
Secondary	Change in Gait Deviation Index 1-year After Orthopaedic Surgery	The Gait Deviation Index is a specific measurement which uses kinematics measured from instrumented gait analysis to compare an individual's gait pattern to typically-developing controls. A value of 100 indicates kinematics similar to unimpaired individuals while each 10 point deviation represents one standard deviation from unimpaired gait. Thus, a value of 80 would indicate that an individual's gait kinematics are on average two standard deviations from unimpaired gait.	1-year after individual's orthopaedic surgery