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Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy 120 Adolescent

Active, not recruiting
Clinical Trial NCT04360395 is an interventional study for Cerebral Palsy that is active, not recruiting. It started on 3 August 2020 with plans to enroll 120 participants. Led by Father Flanagan's Boys' Home, it is expected to complete by 31 May 2026. The latest data from ClinicalTrials.gov was last updated on 29 September 2025.
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 ...Show More
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 breakthro...Show More
Official Title

Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy

Conditions
Cerebral Palsy
Other Study IDs
  • 20-24-XP
NCT ID Number
Start Date (Actual)
2020-08-03
Last Update Posted
2025-09-29
Completion Date (Estimated)
2026-05-31
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
Cerebral Palsy
Gait therapy
Mobility
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No InterventionNeurotypical Youth/Young Adults
No intervention administered. The controls will only undergo initial baseline assessments.
N/A
ExperimentalCerebral Palsy Youth/Young Adults
Baseline and 8 week assessments; 8 week gait therapy
Gait therapy
The therapeutic gait training protocol will consist of 24-treatment sessions that will be performed 3 times-a-week for an 8-week period. All therapeutic exercises will be performed under the direction of a licensed pediatric physical therapist. Any sessions missed will be added on to the 8-week period. Each intervention session will consist of over-ground gait activities that will be completed in a 60 minute session ...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in Mobility Test Time
The participant will be asked to perform a series of timed (in seconds) 10-meter walking tasks.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Change in Time for Community Ambulation
The participants will walk along a 400 meter course laid out on the Boys Town campus that incorporates uphill/downhill grades, stairs, curbs, grass and uneven surfaces. The time (in seconds) to complete the course will be used as an outcome variable.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Change in Time for "Timed Up and Go"
The participant will start the test by sitting on a bench. The time (in seconds) it takes the participant to stand-up, walk to a line on the floor that is 3-meters away and return back to sitting on the bench will be the outcome measure.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Change in Selective Control Assessment of the Lower Extremity
This is a clinical assessment where the participant is asked to isolate and move the lower extremity joints. The examiner grades the amount of movement and the ability of the participant to isolate the control. A grade of 0 indicates the participant cannot move the joint, 1 indicates the participant can move the joint but it is impaired, and 2 indicates normal movement of the joint.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Change in Level of Spasticity
Modified Ashworth: This is a clinical assessment where the therapist passively moves the participant's joints and rates the level of spasticity. Scores range from 0-5, where 0 indicates no tone, 5 indicates rigidity.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Change in Isolation of Movement
This is a clinical assessment where the participant is asked to isolate and move the lower extremity joints. The examiner grades the amount of movement and the ability of the participant to isolate the control. A grade of 0 indicates the participant cannot move the joint, 1 indicates the participant can move the joint but it is impaired, and 2 indicates normal movement of the joint.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Change in Brain Activity in Sensory Cortices
Magnetoencephalogram (MEG) or electroencephalogram (EEG) scan: The frequency bands of interest include theta (4-8 Hz), alpha (8-12 Hz), beta(15-30 Hz) and gamma (\>30 Hz).
Baseline (CP and Neurotypical) and 8 weeks (CP)
Change in Motor Response
Percutaneous electrical stimulations of the femoral nerve applied via an anode that is positioned on the patella and a cathode that is positioned on the popliteal fossa will be applied to the right leg. A wireless surface EMG sensor positioned on the soleus will measure the motor response. The muscular (M-wave) will be assessed while resting and walking.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Change in Hoffmann Reflex
Percutaneous electrical stimulations of the femoral nerve applied via an anode that is positioned on the patella and a cathode that is positioned on the popliteal fossa will be applied to the right leg. A wireless surface EMG sensor positioned on the soleus will measure the Hoffmann reflex. The spinal reflexes (H-wave) will be assessed while resting and walking.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Cognitive related changes induced via physical therapy -Wide Range Assessment of Memory and Learning (WRAML)
Subtests: Finger Windows, Picture Memory, Symbolic Working Memory: A standardized test that measures memory functioning, evaluating both immediate and delayed memory ability in addition to the acquisition of new learning. Viable for young children and adults.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - D2 - Test of Attention
A neuropsychological measure of selective and sustained attention in addition to visual scanning speed. Participants are tasked with crossing out any letter "d" with two marks around above it or below it in any order, in a mix of other letters and with various numbers of marks around them. Viable for young children and adults.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Trail Making A+B
A neuropsychological test of visual attention and task switching. The subject is tasked to connect a set of numbered 25 dots as quickly as possible while still maintaining accuracy, with the second test increasing in cognitive load by introducing letters as well. Viable for young children and adults.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - WAIS-IV Digit Span - Youth + Adult
A subtest of the Wechsler Memory Scales (WMS), subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span) to measure short term memory capacity in young children and adults.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Stroop Test - Youth + Adult
A neuropsychological test that assesses the ability to inhibit cognitive interference during the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute (the Stroop Effect). The Stroop Effect is the delay in reaction time between congruent and incongruent stimuli, Such that a mismatch between the name of a color (e.g., "blue", "green", or "red") and the color it is printed on (i.e., the word "red" printed in blue ink instead of red ink).
Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) Questionnaire
Children with severe developmental disabilities are often dependent on parents/caregivers for much of their daily needs. These children often have multiple co-morbid conditions which can have a significant impact on their overall health and quality of life. Interventions are aimed at preserving or improving their health, comfort and quality of life and to facilitate caregiving. CP CHILD is an instrument that aims to measure these phenomena. Respondents rate a number of areas including the difficulty of activities for their child (Scale ranging from 0-Not Possible to 6-No problem at all) and choose the level of assistance needed to perform these activities (Scale ranging from 0-Total to 3-Independent), how often their child experience pain or discomfort (Scale ranging from 0-Every day to 5-None of the time) and intensity (0-Severe to 3-None), importance of items in child's quality of life (0-Least Important to 5-Most Important), and overall health of child (0-Very Poor to 5-Excellent).
Baseline (CP) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Silver Linings Questionnaire - Adapted for CP
A survey measure that examines the extent to which people believe their illness - in this case the questionnaire has been adapted to individuals with CP, has had a positive benefit despite the negative consequences of having CP. Participants indicate the extent to which they agree or disagree with each statement by circling a number between 5 "strongly agree" and 1 "strongly disagree"
Baseline (CP) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Child and Adolescent Sleep Checklist (CASC)
Tool designed to identify sleep habits and to make a screening of sleep problems among preschoolers, elementary school children, and high school students.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - PEDS QL Fatigue Questionnaire (Acute)
The PedsQL Multidimensional Fatigue Scale is a symptom-specific instrument to measure fatigue across pediatric populations. It measures cognitive fatigue which focuses on problems with memory and attention, areas known to be affected in children with CP, on a scale ranging from 0-if it is never a problem and 4-if it is almost always a problem.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Pittsburgh Sleep Quality Index (PSQI)
An effective instrument used to measure the quality and patterns of sleep in adults.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - MacArthur Scale of Subjective Social Status Youth + Adult
Adult Version: This tool for adults, uses a pictorial representation of a symbolic ladder, developed to capture the common sense of social status based on usual socioeconomic status indicators. It has the additional advantage to allow comparisons between studies conducted in different populations. Youth Version: This tool is a two-item instrument that measures a how a young person perceives their family's and their own social standing The symbolic ladder has 10 rungs. The higher the rung, the higher the perceived social status.
Baseline (CP and Neurotypical) and 8 weeks (CP)
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
13 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • For Cerebral Palsy participants:

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

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

  • No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI.
Father Flanagan's Boys' Home logoFather Flanagan's Boys' Home
Study Responsible Party
Max Kurz, Principal Investigator, Director of PoWER Lab, Father Flanagan's Boys' Home
No contact data.
1 Study Locations in 1 Countries

Nebraska

Boys Town National Research Hospital, Boys Town, Nebraska, 68010, United States