Clinical trial NCT02699554: Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy
Official title: Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Gillette Children's Specialty Healthcare
First posted: 2016-03-04
Enrollment: 55
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery
timeFrame: 6-months after individual's orthopaedic surgery
measure: Change in Walk Dynamic Motor Control Index 1-year After Orthopaedic Surgery
timeFrame: 1-year after individual's orthopaedic surgery
Secondary outcomes:
measure: Change in Gait Deviation Index 6-months After Orthopaedic Surgery
timeFrame: 6-months after individual's orthopaedic surgery
measure: Change in Gait Deviation Index 1-year After Orthopaedic Surgery
timeFrame: 1-year after individual's orthopaedic surgery
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
Study officials:
affiliation: University of Washington
name: Katherine M Steele, PhD
role: PRINCIPAL_INVESTIGATOR
References: