Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy

NCT ID: NCT02699554

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-09-30

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.

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.

Conditions

Cerebral Palsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Orthopaedic surgery

Single-event multilevel surgery

Intervention Type: PROCEDURE

Interventions

Single-event multilevel surgery

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Gillette Children's Specialty Healthcare

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Katherine Steele

Assistant Professor, Mechanical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine M Steele, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1R01NS091056-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

44170

Identifier Type: -

Identifier Source: org_study_id