Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy

NCT02699554 | Completed Results

• 2 other identifiers: 441701R01NS091056-01A1
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in Gait Deviation Index 6-months After Orthopaedic Surgery

  6-months after individual's orthopaedic surgery

• Change in Gait Deviation Index 1-year After Orthopaedic Surgery

  1-year after individual's orthopaedic surgery

Study Arms (1)

Orthopaedic surgery

Procedure: Single-event multilevel surgery

Interventions

Single-event multilevel surgery PROCEDURE

Orthopaedic surgery

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Gillette Children's Specialty Healthcare: collaborator

Study Sites (1)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This was a prospective observational cohort study, not a randomized controlled trial. 32 of the 55 participants returned for the 6-month post-operative gait analysis and 46 of the 55 participants returned for the 12-month post-operative gait analysis.

Results Point of Contact

• Title: Katherine Steele
• Organization: University of Washington

kmsteele@uw.edu

206-685-2390

Study Officials

• Katherine M Steele, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Mechanical Engineering

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: March 4, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-05

Locations

US (1)