Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Cerebral Palsy
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Parallel AssignmentIntervention Model Description: Cerebral Palsy participants will undergo baseline mobility/brain imaging/cognitive testing, receive gait therapy, and then repeat mobility/brain imaging testing. Non-Cerebral Palsy controls will undergo the same baseline testing once as a reference group to determine a normative state for mobility. No gait therapy will be conducted.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 13 years and 18 years
Gender
Both males and females

Description

Cerebral palsy (CP) results from a perinatal brain injury and is one of the most prevalent and costly pediatric neurologic conditions in the United States that often results in mobility deficits. The investigator's extensive experimental work has been focused on developing a therapeutic gait trainin...

Cerebral palsy (CP) results from a perinatal brain injury and is one of the most prevalent and costly pediatric neurologic conditions in the United States that often results in mobility deficits. The investigator's extensive experimental work has been focused on developing a therapeutic gait training protocol that will improve the long-term mobility of adolescents and young adults with CP. Despite the major breakthroughs, it is apparent across the investigations that some patients have vast improvements in their mobility after treatment, while others are clearly non-responders. This response variability represents one of the major Gordian knots in the treatment outcomes seen in adolescents and young adults with CP. The investigator will address this knowledge gap with a multimodal approach that blends the investigator's expertise in MEG/EEG brain imaging, MRI spinal cord imaging, and assessments of the spinal cord interneuronal circuitry to probe the neurophysiological differences in participants that are classified as responders and non-responders after therapeutic gait training. The Specific Aims of this study will: (1) identify if responders and non-responders have differences in the strength of the sensorimotor cortical oscillations involved in the planning and execution of a leg motor action, (2) determine if responders and non-responders have differences in the neural synchrony within the somatosensory cortices, following stimulation of the foot mechanoreceptors, and (3) decipher if responders and non-responders have differences in the spinal cord microstructure and circuitry dynamics. (4) Secondary aim: assess cognitive related changes induced via physical therapy. Briefly, the study design consists of a cohort of adolescents and young adults with CP that will initially undergo MEG/EEG brain imaging, MRI spinal cord imaging, neurophysiological tests of the spinal cord interneuronal circuitry, cognitive testing, and clinical mobility assessments. After completing the baseline tests, the participants will undergo the therapeutic gait training protocol. Upon completion of the treatment program, the participants will repeat the same assessments that were completed at baseline. Separation of the participants into responders and non-responders to treatment will be based on the criteria for a clinically relevant change in the 10-meter walking speed test. The new data derived from this project will provide unparalleled insight on the potential neurophysiological origins of the diverse mobility outcomes seen in adolescents and young adults with CP after treatment. Finally, an additional cohort of neurotypical adolescents and young adults of similar age and sex will also complete the mobility, MEG/EEG, spinal cord imaging, and Hoffmann reflex protocols for comparative purposes.

Tracking Information

NCT #
NCT04360395
Collaborators
Not Provided
Investigators
Principal Investigator: Max J Kurz, PhD Father Flanagan's Boys' Home