临床试验雷达

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)

Cognitive related changes induced via physical therapy -Wide Range Assessment of Memory and Learning (WRAML)

Subtests: Finger Windows, Picture Memory, Symbolic Working Memory:

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 Neurotypical) 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

Baseline (CP and Neurotypical) 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.

Baseline (CP and Neurotypical) and 8 weeks (CP)