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Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02699554
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Gillette Children's Specialty Healthcare
Information provided by (Responsible Party):
Katherine Steele, University of Washington

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Cerebral Palsy Procedure: Single-event multilevel surgery

Detailed 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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy
Study Start Date : September 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Orthopaedic surgery Procedure: Single-event multilevel surgery


Outcome Measures
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Primary Outcome Measures :
  1. Change in Walk Dynamic Motor Control Index 6-months after orthopaedic surgery [ Time Frame: 6-months after individual's 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. For full methods used to calculate Walk DMC please see: Steele, K. M., Rozumalski, A., & Schwartz, M. H. (2015). Muscle synergies and complexity of neuromuscular control during gait in cerebral palsy. Developmental Medicine & Child Neurology, 57(12), 1176-1182.

  2. Change in Walk Dynamic Motor Control Index 1-year after orthopaedic surgery [ Time Frame: 1-year after individual's 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. For full methods used to calculate Walk DMC please see: Steele, K. M., Rozumalski, A., & Schwartz, M. H. (2015). Muscle synergies and complexity of neuromuscular control during gait in cerebral palsy. Developmental Medicine & Child Neurology, 57(12), 1176-1182.


Secondary Outcome Measures :
  1. Change in Gait Deviation Index 6-months after orthopaedic surgery [ Time Frame: 6-months after individual's 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. Reference: Schwartz, M. H., & Rozumalski, A. (2008). The Gait Deviation Index: a new comprehensive index of gait pathology. Gait & posture, 28(3), 351-357.

  2. Change in Gait Deviation Index 1-year after orthopaedic surgery [ Time Frame: 1-year after individual's 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. Reference: Schwartz, M. H., & Rozumalski, A. (2008). The Gait Deviation Index: a new comprehensive index of gait pathology. Gait & posture, 28(3), 351-357.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with cerebral palsy, diplegia subtype, with mild or moderate impairment, Gross Motor Function Classification System (GMFCS) Levels I-III, between the ages of 6 - 18.
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699554


Contacts
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Contact: Katherine M Steele, PhD 206-685-2390 kmsteele@uw.edu
Contact: Keshia M Peters, BS 206-221-6153 rumbek@uw.edu

Locations
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United States, Minnesota
Gillette Children's Specialty Healthcare Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Michael Schwartz, PhD    651-229-3929    schwa021@umn.edu   
Sponsors and Collaborators
University of Washington
National Institute of Neurological Disorders and Stroke (NINDS)
Gillette Children's Specialty Healthcare
Investigators
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Principal Investigator: Katherine M Steele, PhD University of Washington
More Information
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Additional Information:

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Responsible Party: Katherine Steele, Assistant Professor, Mechanical Engineering, University of Washington
ClinicalTrials.gov Identifier: NCT02699554     History of Changes
Other Study ID Numbers: 44170
1R01NS091056-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases