Clinical trial NCT04360395: Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy
Official title: Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Gait therapy
Mobility
Lead sponsor: Father Flanagan's Boys' Home
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: The study design will consist of a cohort of adolescents and young adults with cerebral palsy (CP) that will undergo a gait training protocol. All participants will complete MEG or EEG baseline brain imaging measures of their sensorimotor cortical activity, MRI brain/spinal cord imaging (previous MRI or template brain may be substituted), neurophysiological tests of the spinal cord H-reflex, and a series of mobility clinical tests and cognitive tests. Participants with metal in their body that would interfere with the MEG (e.g., braces on teeth, permanent retainer) will not undergo the MEG tests but will undergo the EEG assessments. Those who complete the MEG assessments will not undergo the EEG assessments.

After completing the baseline tests, the participants with CP will undergo the therapeutic gait training. After completing all of the therapeutic gait training sessions, the participants with CP will repeat the same assessments that were completed at baseline.

Separately, a cohort of neurotypical adolescents and young adults will also complete the baseline assessments. The neurotypical participants will not undergo the therapeutic gait training, but will be used as a normative group for interpreting if the changes seen in the participants with CP after therapy are in fact moving the system toward a normative state.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* For Cerebral Palsy participants:

  * Cerebral Palsy diagnosis
* For Non-Cerebral Palsy Controls:

  * No known atypical neurodevelopment (e.g autism, Down Syndrome, ADHD, etc.)

Exclusion Criteria:

* No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI.

Primary outcomes:
measure: Change in Mobility Test Time
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Time for Community Ambulation
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Time for "Timed Up and Go"
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Selective Control Assessment of the Lower Extremity
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Level of Spasticity
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Isolation of Movement
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Brain Activity in Sensory Cortices
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Motor Response
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Hoffmann Reflex
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Secondary outcomes:
measure: Cognitive related changes induced via physical therapy -Wide Range Assessment of Memory and Learning (WRAML)
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - D2 - Test of Attention
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Trail Making A+B
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - WAIS-IV Digit Span - Youth + Adult
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Stroop Test - Youth + Adult
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) Questionnaire
timeFrame: Baseline (CP) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Silver Linings Questionnaire - Adapted for CP
timeFrame: Baseline (CP) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Child and Adolescent Sleep Checklist (CASC)
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - PEDS QL Fatigue Questionnaire (Acute)
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - MacArthur Scale of Subjective Social Status Youth + Adult
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Other outcomes:
Locations:
city: Boys Town
country: United States
facility: Boys Town National Research Hospital
state: Nebraska
Study officials:
affiliation: Father Flanagan's Boys' Home
name: Max J Kurz, PhD
role: PRINCIPAL_INVESTIGATOR
References: