Cerebral PalsyNCT05158218
Robotic Exoskeleton Gait Training in Adolescents With Cerebral Palsy
A study testing Robotic Exoskeleton Gait Therapy and Physical Therapy in people with Cerebral Palsy, run by Father Flanagan's Boys' Home at 1 site in United States.
Trial 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 baseline brain imaging measures of their sensorimotor cortical activity, MRI brain/spinal cord imaging (previous MRI or template brain may be… Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Robotic Exoskeleton Gait Therapy and Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For Cerebral Palsy participants:
- Cerebral Palsy diagnosis
- For Non-Cerebral Palsy Controls:
- No known atypical neurodevelopment (e.g autism, Down Syndrome, ADHD, etc.)
Who cannot join
- No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boys Town National Research Hospital
Boys Town, Nebraska, 68010
About this study
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.
Read the 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. Robotic exoskeletons have gained recent attention in the therapeutic community as a high-tech option for assisting with over-ground mobility of various patient populations. The goal of this investigation is to take a fresh new approach on how robotic exoskeletons can be used in a therapeutic setting. As opposed to using them as a compensation tool, we are proposing to use them to perturb the legs to drive beneficial neuroplasticity in the key brain areas that govern the leg motor actions. Essentially, we predict that the neuroplastic changes promoted by the exoskeleton gait training protocol will lead to more robust clinical outcomes than what is seen by gait training alone. The aims of this study will: (1) determine if individuals with CP that undergo a robotic exoskeleton gait training protocol have larger mobility improvements compared to those that undergo gait training alone, (2) determine if individuals that undergo a robotic exoskeleton gait training protocol have larger improvements in key brain areas involved in motor planning and execution of the leg motor actions compared to those that undergo gait training alone, and (3) determine if individuals with CP that undergo a robotic exoskeleton gait training protocol have larger mobility improvements compared to those that undergo gait training alone. It is hypothesized after exoskeleton gait training participants will demonstrate substantially greater improvements in their 10-meter walk speed, one-minute walk test, and Functional Gait Assessment scores. Additionally, following exoskeleton training, the sensorimotor cortical activity will be significantly different from what is seen in those receiving gait training alone. Furthermore, the degree of brain activity changes will be related to the extent of the mobility improvements seen after completing the exoskeleton gait training protocol. Briefly, the study design consists of a cohort of adolescents and young adults with CP that will initially undergo MEG brain imaging, MRI spinal cord imaging, neurophysiological tests of the spinal cord interneuronal circuitry, and clinical mobility assessments. After completing the baseline tests, the participants will undergo either traditional therapeutic gait training or utilize the robotic exoskeleton gait therapy. Upon completion of the treatment program, participants will undergo the same baseline assessments. The results from the post therapy outcomes will be compared between the two groups: traditional gait therapy and robotic exoskeleton.
- Conditions
- Cerebral Palsy
- Being tested
- Robotic Exoskeleton Gait Therapy, Physical Therapy
- Keywords
- Cerebral Palsy, Gait Therapy, Mobility, Robotic Exoskeleton
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Exoskeleton Gait TherapyBehavioural
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.
Physical TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy Youth/Young Adults Physical Therapy | Active comparator | Baseline and 8 week assessments; 8 week gait therapy Receives: Behavioral: Physical Therapy |
| Cerebral Palsy Youth/Young Adults Robotic Exoskeleton | Experimental | Baseline and 8 week assessments; 8 week gait therapy using robotic exoskeleton Receives: Behavioral: Robotic Exoskeleton Gait Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mobility Test Time
The participant will be asked to perform a series of timed (in seconds) 10-meter walking tasks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline (CP and Neurotypical) and 8 weeks (CP)
Secondary outcomes (11)
Cognitive related changes induced via physical therapy -Wide Range Assessment of Memory and Learning (WRAML)
Subtests: Finger Windows, Picture Memory, Symbolic Working Memory:
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (CP and Neurotypical) and 8 weeks (CP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start2 Dec 2021
- Primary completion1 Jan 2025
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cerebral Palsy participants will undergo baseline mobility/brain imaging/cognitive testing, receive traditional gait therapy, and then repeat mobility/brain imaging testing. Cerebral Palsy participants will undergo baseline mobility/brain imaging/cognitive testing, receive gait therapy utilizing robotic exoskeleton, and then repeat mobility/brain imaging testing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Father Flanagan's Boys' Home
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Kurz, Father Flanagan's Boys' Home
- Investigators
- Max J Kurz, PhD, Principal investigator, Father Flanagan's Boys' Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158218
- Sponsor's protocol ID
- 21-12-XP
- Status last verified
- May 2026
- First submitted
- 2 Dec 2021
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI and all of the investigators have made a commitment to publish, in a timely manner, all of the relevant scientific information that they will derive during this project. Deidentified data will be made available upon reasonable request to the Principal Investigator (Dr. Kurz).
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Exoskeleton Gait Training in Adolescents With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05158218
- Acronym / sponsor ID
- 21-12-XP
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Gait Therapy, Mobility, Robotic Exoskeleton
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Father Flanagan's Boys' HomeUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Robotic exoskeletons have gained recent attention in the therapeutic community as a high-tech option for assisting with over-ground mobility of various patient populations. The goal of this investigation is to take a fresh new approach on how robotic exoskeletons can be used in a therapeutic setting. As opposed to using them as a compensation tool, we are proposing to use them to perturb the legs to drive beneficial neuroplasticity in the key brain areas that govern the leg motor actions. Essentially, we predict that the neuroplastic changes promoted by the exoskeleton gait training protocol will lead to more robust clinical outcomes than what is seen by gait training alone. The aims of this study will: (1) determine if individuals with CP that undergo a robotic exoskeleton gait training protocol have larger mobility improvements compared to those that undergo gait training alone, (2) determine if individuals that undergo a robotic exoskeleton gait training protocol have larger improvements in key brain areas involved in motor planning and execution of the leg motor actions compared to those that undergo gait training alone, and (3) determine if individuals with CP that undergo a robotic exoskeleton gait training protocol have larger mobility improvements compared to those that undergo gait training alone. It is hypothesized after exoskeleton gait training participants will demonstrate substantially greater improvements in their 10-meter walk speed, one-minute walk test, and Functional Gait Assessment scores. Additionally, following exoskeleton training, the sensorimotor cortical activity will be significantly different from what is seen in those receiving gait training alone. Furthermore, the degree of brain activity changes will be related to the extent of the mobility improvements seen after completing the exoskeleton gait training protocol. Briefly, the study design consists of a cohort of adolescents and young adults with CP that will initially undergo MEG brain imaging, MRI spinal cord imaging, neurophysiological tests of the spinal cord interneuronal circuitry, and clinical mobility assessments. After completing the baseline tests, the participants will undergo either traditional therapeutic gait training or utilize the robotic exoskeleton gait therapy. Upon completion of the treatment program, participants will undergo the same baseline assessments. The results from the post therapy outcomes will be compared between the two groups: traditional gait therapy and robotic exoskeleton.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cerebral Palsy participants will undergo baseline mobility/brain imaging/cognitive testing, receive traditional gait therapy, and then repeat mobility/brain imaging testing. Cerebral Palsy participants will undergo baseline mobility/brain imaging/cognitive testing, receive gait therapy utilizing robotic exoskeleton, and then repeat mobility/brain imaging testing.
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy Youth/Young Adults Physical Therapy | Active comparator | Behavioral: Physical TherapyBaseline and 8 week assessments; 8 week gait therapy |
| Cerebral Palsy Youth/Young Adults Robotic Exoskeleton | Experimental | Behavioral: Robotic Exoskeleton Gait TherapyBaseline and 8 week assessments; 8 week gait therapy using robotic exoskeleton |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- For Cerebral Palsy participants:
- For Non-Cerebral Palsy Controls:
Key exclusion criteria (1 listed)
- No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Exoskeleton Gait TherapyThe 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. | Behavioural | Cerebral Palsy Youth/Young Adults Robotic Exoskeleton |
| Physical TherapyThe 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 | Behavioural | Cerebral Palsy Youth/Young Adults Physical Therapy |
Primary outcome
Change in Mobility Test Time
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
The participant will be asked to perform a series of timed (in seconds) 10-meter walking tasks.
Change in Time for Community Ambulation
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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.
Change in Time for "Timed Up and Go"
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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.
Change in Selective Control Assessment of the Lower Extremity
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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.
Change in Level of Spasticity
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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.
Change in Isolation of Movement
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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.
Change in Brain Activity in Sensory Cortices
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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).
Change in Motor Response
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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.
Change in Hoffmann Reflex
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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.
11 secondary outcomes
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)
Cognitive related changes induced via physical therapy - D2 - Test of Attention
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Trail Making A+B
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - WAIS-IV Digit Span - Youth + Adult
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Stroop Test - Youth + Adult
Time frame: 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
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Silver Linings Questionnaire - Adapted for CP
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Child and Adolescent Sleep Checklist (CASC)
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - PEDS QL Fatigue Questionnaire (Acute)
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Cognitive related changes induced via physical therapy - Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. The PI and all of the investigators have made a commitment to publish, in a timely manner, all of the relevant scientific information that they will derive during this project. Deidentified data will be made available upon reasonable request to the Principal Investigator (Dr. Kurz).
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max J Kurz, PhD principal investigator
Father Flanagan's Boys' Home
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Exoskeleton Gait Therapy and Physical Therapy in people with Cerebral Palsy, run by Father Flanagan's Boys' Home at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mobility Test Time (time frame: Baseline (CP and Neurotypical) and 8 weeks (CP)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.