- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05158218
Robotic Exoskeleton Gait Training in Adolescents With Cerebral Palsy
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 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.
After completing the baseline tests, the participants with CP will undergo the therapeutic gait training using either traditional physical therapy or utilizing a robotic exoskeleton. After completing all of the therapeutic gait training sessions, the participants will repeat the same assessments that were completed at baseline. The two groups will be compared based on the assessments for therapeutic outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Max J Kurz, PhD
- Phone Number: 531-355-8916
- Email: max.kurz@boystown.org
Study Locations
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Nebraska
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Boys Town, Nebraska, United States, 68010
- Recruiting
- Boys Town National Research Hospital
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Contact:
- Max J Kurz, PhD
- Phone Number: 402-559-6415
- Email: max.kurz@boystown.org
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Principal Investigator:
- Max J Kurz, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cerebral Palsy Youth/Young Adults Physical Therapy
Baseline and 8 week assessments; 8 week gait therapy
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The 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 with rests as needed.
The key ingredients of the therapy will include: 1) activities of adequate intensity that promote gait adaptation and gait speed sustainment, 2) exploratory activities that enhance the somatosensory experience through rich/novel movement, and 3) optimally challenging activities that emphasize planning and problem solving that requires altering the leg kinematics to meet the environmental and task constraints.
An overhead body weight support system or a gait-belt may be used for some individuals during the gait training blocks
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Experimental: Cerebral Palsy Youth/Young Adults Robotic Exoskeleton
Baseline and 8 week assessments; 8 week gait therapy using robotic exoskeleton
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The 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 physical therapist.
Any sessions missed will be added on to the 8-week period.
Each intervention session will be completed in a 60-minute sessions with rests as needed.
The key components of the therapy will include: 1) optimally challenging activities of variable intensity that emphasize motor planning and problem solving that requires altering the leg kinematics to meet the environmental and task constraints, 2) task specific overground movements that promote building a repertoire of mobility strategies that can be utilized in the community, and 3) motor tasks requiring active control that increase participant therapeutic engagement.
An overhead body weight support system or a gait-belt may be used for some individuals during the robotic exoskeleton gait training blocks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mobility Test Time
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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The participant will be asked to perform a series of timed (in seconds) 10-meter walking tasks.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Change in Time for Community Ambulation
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Change in Time for "Timed Up and Go"
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Change in Selective Control Assessment of the Lower Extremity
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Change in Level of Spasticity
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Change in Isolation of Movement
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Change in Brain Activity in Sensory Cortices
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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).
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Change in Motor Response
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Change in Hoffmann Reflex
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive related changes induced via physical therapy - D2 - Test of Attention
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Cognitive related changes induced via physical therapy - Trail Making A+B
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Cognitive related changes induced via physical therapy - WAIS-IV Digit Span - Youth + Adult
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Cognitive related changes induced via physical therapy - Stroop Test - Youth + Adult
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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).
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Cognitive related changes induced via physical therapy - Child and Adolescent Sleep Checklist (CASC)
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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Tool designed to identify sleep habits and to make a screening of sleep problems among preschoolers, elementary school children, and high school students.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Cognitive related changes induced via physical therapy - PEDS QL Fatigue Questionnaire (Acute)
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Cognitive related changes induced via physical therapy - Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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An effective instrument used to measure the quality and patterns of sleep in adults.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Cognitive related changes induced via physical therapy -Wide Range Assessment of Memory and Learning (WRAML)
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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Subtests: Finger Windows, Picture Memory, Symbolic Working Memory:
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Cognitive related changes induced via physical therapy - Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) Questionnaire
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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).
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Cognitive related changes induced via physical therapy - Silver Linings Questionnaire - Adapted for CP
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Cognitive related changes induced via physical therapy - MacArthur Scale of Subjective Social Status Youth + Adult
Time Frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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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.
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Baseline (CP and Neurotypical) and 8 weeks (CP)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Max J Kurz, PhD, Father Flanagan's Boys' Home
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-12-XP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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