Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy

• ClinicalTrials.gov Identifier: NCT02699554
• Recruitment Status: Completed
• First Posted: March 4, 2016
• Results First Posted: May 9, 2022
• Last Update Posted: May 9, 2022
• Sponsor: University of Washington
• 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

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

• Study Type: Observational [Patient Registry]
• Actual 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
• Actual Study Start Date: September 2015
• Actual Primary Completion Date: September 2020
• Actual Study Completion Date: September 2020

Groups and Cohorts

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

Outcome Measures

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.
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 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.
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.

Eligibility Criteria

• 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

Locations

United States, Minnesota

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, United States, 55101

Sponsors and Collaborators

University of Washington

National Institute of Neurological Disorders and Stroke (NINDS)

Gillette Children's Specialty Healthcare

Investigators

• Principal Investigator: Katherine M Steele, PhD; University of Washington

  Study Documents (Full-Text)

Documents provided by Katherine Steele, University of Washington:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] March 15, 2022

More Information

Additional Information:

• Responsible Party: Katherine Steele, Assistant Professor, Mechanical Engineering, University of Washington
• ClinicalTrials.gov Identifier: NCT02699554
• Other Study ID Numbers: 44170; 1R01NS091056-01A1 ( U.S. NIH Grant/Contract )
• First Posted: March 4, 2016
• Results First Posted: May 9, 2022
• Last Update Posted: May 9, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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