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Completed

NCT Number: NCT02699554

Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single-event multilevel surgery

Procedure

Primary outcomes

  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.

  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.

Secondary outcomes

  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.

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Gillette Children's Specialty Healthcare
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 4, 2016
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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