Cerebral Palsy (CP)STEP-CPNCT07752030
Sampling Therapeutic Effects and Progress in Cerebral Palsy (STEP-CP)
A study testing Physical Therapy Gait Training in people with Cerebral Palsy (CP), run by Father Flanagan's Boys' Home at 1 site in United States.
Trial summary
Cerebral palsy (CP) results from an early brain injury that can have cascading effects on the neuromuscular system and often results in life-long mobility impairments. An extensive amount of research funding has been dedicated towards identifying physical therapy treatment strategies that will overcome the spectrum of… Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Physical Therapy Gait Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2026to Jun 2030
- 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 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Persons with a diagnosis of cerebral palsy.
Who cannot join
- Participants not able to stand or initiate gait movement without assistance.
- Unable to walk for 1-minute with or without a mobility aide (i.e., forearm crutches, wheeled walker)
- Have had orthopedic surgery within the last 6 months.
- Metal in their body that would preclude neuroimaging.
- Current pregnancy or suspected pregnancy.
- Currently on steroid medication (i.e., birth control).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boys Town National Research Hospital
Omaha, Nebraska, 68010
About this study
Cerebral palsy (CP) results from an early brain injury that can have cascading effects on the neuromuscular system and often results in life-long mobility impairments. An extensive amount of research funding has been dedicated towards identifying physical therapy treatment strategies that will overcome the spectrum of mobility impairments seen in person with CP. Surveillance of the clinical trials conducted to date reveals that there are a limited number of gait training treatment strategies with sufficient evidence that they should be implemented into clinical practice. Rather the outcomes from the clinical trials have been mixed with some individuals responding very well to physical therapy, while others appear to have barriers that limit their breakthroughs. Unfortunately, we have a substantial knowledge gap in our ability to identify the neurophysiological fingerprint for those that will respond well to the latest physical therapy trends and those that will not respond as well. The investigators recent neuroimaging outcomes are the first to reveal that persons classified as non-responders based on the walking speed clinical outcomes tend to display alterations in the activity of the prefrontal and premotor cortical areas. Remarkably, these same cortical areas have also been identified as potential biomarkers for the recovery of adults that have incurred a stroke. Although these insights are groundbreaking, they are based on pre- and post-physical therapy assessments. This limits the investigators understanding of where in the course of the treatment that an individual may have diverged from optimizing their mobility. Identifying the neurophysiological basis for these divergent time points has the potential for revealing more refined biomarkers for identifying why an individual with CP doesn't respond to a specific treatment and treatment strategies for intervening on the treatment direction. For example, if the investigator's data shows that an individual that doesn't respond as well lacks neuroplastic changes in the cortical areas that process sensory information, then augmenting the therapy with tasks that heighten the attention and recognition of sensory information might promote new breakthroughs for the individual patient. The overall purpose of the STEP-CP investigation is to employ dense sampling methods to evaluate the week-by-week neuroplastic changes seen across the therapeutic intervention and evaluate how they are connected with the extent of the weekly clinical gains or lack thereof.
Read the detailed description
The overall landscape of this investigation involves you undergoing an 8-week gait training intervention that will be led by a licensed physical therapist. You will initially complete a battery of baseline MEG neuroimaging and clinical mobility assessments. Each week of the physical therapy you will repeat the MEG neuroimaging and clinical mobility assessments to quantify the extent of the weekly neuroplastic and mobility gains. You will repeat the same baseline assessments upon completion of the 8-weeks of physical therapy.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Physical Therapy Gait Training
- Keywords
- Physical Therapy, Exercise, brain imaging, hormones
- Medical subject headings
- Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy Gait TrainingBehavioural
Participants will complete 24 gait training sessions (1-hour session, 3 times per week for 8 weeks) under the direction of a licensed physical therapist. The gait training activities will include overground activities such as navigating obstacles of different heights in various terrains, walking up and down stairs, and ambulating at different speeds. The tasks will be matched with the participant's individualized goals and motor abilities to reach the optimal challenge point for each participant. The optimal challenge point will be determined by the individual's engagement, effort, and ability to successfully complete the prescribed tasks. Activities and the task environment will be scaled based on individual progress across the intervention period. Exploration of movement and error-based motor learning will also be emphasized.
| Study group | Role | What they receive |
|---|---|---|
| Gait Training Group | Experimental | Participants receive a goal-directed gait training intervention Receives: Behavioral: Physical Therapy Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEG Neuroimaging
Participants will complete 3 tasks that will be used to quantify the neuroplastic changes in the brain areas that are involved in the control of a leg motor action, processing of somatosensory information and processing of basic visual information. The activity of the brain areas that are involved in the planning and generation of a leg motor action will be assessed with a visually cued task where the participant extends their right knee every time the cue is seen. The activity of the brain areas that process sensory information will be assessed with a paired-pulse, unilateral electrical stimulation that will be applied using electrodes that will be affixed to the skin overlying the right tibial nerve (DS7R; Digitimer, UK). The intensity of stimulation will be set to level that generates a subtle twitch in the toes. The activity of the brain areas that process basic visual information will be assessed by having the participant view a flickering dot on a screen.
Measured: Weekly until 8 weeks
10-meter walk
Each participant's 10-meter preferred, and fast-as-possible walking speeds will be evaluated. Three trials will be completed at each speed, and the fastest of the respective trials will be the key metric. The respective assessments will occur on a digital mat (ProtoKinetics, Havertown PA) that will quantify the spatiotemporal gait kinematics.
Measured: Weekly until 8 weeks
Timed up and go
This is a standard clinical test that is used to assess mobility and dynamic balance. The participant will start the test by sitting on a bench. The time 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: Weekly until 8 weeks
1-minute Walk
Cones that are separated by 12.8 meters will be placed on opposite ends of the clinic and the participant is asked to complete laps around the cones as fast-as-possible.
Measured: Weekly until 8 weeks
Secondary outcomes (5)
Sleep/Activity Monitoring
Participants will wear an ActiGraph wrist monitor during the 8-weeks of physical therapy. The ActiGraph is a compact, wrist-worn, battery-operated monitor with physical characteristics that are similar to a wristwatch. The ActiGraph has an inertia measurement unit (IMU) that is used to quantify body motion in order to quantify an individual's sleep and wake patterns. Weekly, the study staff will download the data to a PC for analysis. The study staff will also send the participant daily text messages, e-mails or phone calls asking for a report on the participant's estimated sleep and wake times. The reported sleep/wake times will be used to streamline the post data processing.
Measured: Daily until 8 weeks
Pittsburg Sleep Quality Index (PSQI)
This questionnaire is directed at quantifying the participant's sleep quality and disturbances. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The component scores are summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: Weekly until 8 weeks
Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) Survey
This survey evaluates how pain impacts and individual's physical, mental and social activities over the previous 7 days. Items are scored from 0-5 with higher scores indicating greater interference from pain. The component scores are summed to obtain a global pain inference score, which ranges from 0 to 30. Scores closer to 30 indicate that pain very much interferes.
Measured: Weekly until 8 weeks
Secondary Hormone measure
Female participants will be asked to complete daily at-home urine testing throughout the 8-weeks of the physical therapy. The samples will be immediately tested using a Mira Hormone Monitor. This monitor is a lab-grade, app-based, secure and HIPPA-compliant device. It uses fluorescent-based technology and a calibrated optical analyzer to estimate hormone levels with clinical-level accuracy.
Measured: Daily until 8 weeks
Daily Menstrual Distress Questionnaire
Female participants will complete this survey that contains 26 questions about mood, pain, cognitive status, health and timing of period. Each item is scored from 0-3, with higher scores indicating that the participant very much has the symptom. The component scores are summed to obtain a global daily menstrual distress score, which ranges from 0 to 78, with higher scores indicating greater menstrual distress.
Measured: Daily until 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752030
- Sponsor's protocol ID
- IRB#26-029
- Acronym
- STEP-CP
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sampling Therapeutic Effects and Progress in Cerebral Palsy (STEP-CP)
- ClinicalTrials.gov ID
- NCT07752030
- Acronym / sponsor ID
- STEP-CP / IRB#26-029
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Physical Therapy, Exercise, brain imaging, hormones
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Father Flanagan's Boys' HomeUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 7 Aug 2026 (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.
Cerebral palsy (CP) results from an early brain injury that can have cascading effects on the neuromuscular system and often results in life-long mobility impairments. An extensive amount of research funding has been dedicated towards identifying physical therapy treatment strategies that will overcome the spectrum of mobility impairments seen in person with CP. Surveillance of the clinical trials conducted to date reveals that there are a limited number of gait training treatment strategies with sufficient evidence that they should be implemented into clinical practice. Rather the outcomes from the clinical trials have been mixed with some individuals responding very well to physical therapy, while others appear to have barriers that limit their breakthroughs. Unfortunately, we have a substantial knowledge gap in our ability to identify the neurophysiological fingerprint for those that will respond well to the latest physical therapy trends and those that will not respond as well. The investigators recent neuroimaging outcomes are the first to reveal that persons classified as non-responders based on the walking speed clinical outcomes tend to display alterations in the activity of the prefrontal and premotor cortical areas. Remarkably, these same cortical areas have also been identified as potential biomarkers for the recovery of adults that have incurred a stroke. Although these insights are groundbreaking, they are based on pre- and post-physical therapy assessments. This limits the investigators understanding of where in the course of the treatment that an individual may have diverged from optimizing their mobility. Identifying the neurophysiological basis for these divergent time points has the potential for revealing more refined biomarkers for identifying why an individual with CP doesn't respond to a specific treatment and treatment strategies for intervening on the treatment direction. For example, if the investigator's data shows that an individual that doesn't respond as well lacks neuroplastic changes in the cortical areas that process sensory information, then augmenting the therapy with tasks that heighten the attention and recognition of sensory information might promote new breakthroughs for the individual patient. The overall purpose of the STEP-CP investigation is to employ dense sampling methods to evaluate the week-by-week neuroplastic changes seen across the therapeutic intervention and evaluate how they are connected with the extent of the weekly clinical gains or lack thereof.
Detailed description
The overall landscape of this investigation involves you undergoing an 8-week gait training intervention that will be led by a licensed physical therapist. You will initially complete a battery of baseline MEG neuroimaging and clinical mobility assessments. Each week of the physical therapy you will repeat the MEG neuroimaging and clinical mobility assessments to quantify the extent of the weekly neuroplastic and mobility gains. You will repeat the same baseline assessments upon completion of the 8-weeks of physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait Training Group | Experimental | Behavioral: Physical Therapy Gait TrainingParticipants receive a goal-directed gait training intervention |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Persons with a diagnosis of cerebral palsy.
Key exclusion criteria (6 listed)
- Participants not able to stand or initiate gait movement without assistance.
- Unable to walk for 1-minute with or without a mobility aide (i.e., forearm crutches, wheeled walker)
- Have had orthopedic surgery within the last 6 months.
- Metal in their body that would preclude neuroimaging.
- Current pregnancy or suspected pregnancy.
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 |
|---|---|---|
| Physical Therapy Gait TrainingParticipants will complete 24 gait training sessions (1-hour session, 3 times per week for 8 weeks) under the direction of a licensed physical therapist. The gait training activities will include overground activities such as navigating obstacles of different heights in various terrains, walking up and down stairs, and ambulating at different speeds. The tasks will be matched with the participant's individualized goals and motor abilities to reach the optimal challenge point for each participant. The optimal challenge point will be determined by the individual's engagement, effort, and ability to successfully complete the prescribed tasks. Activities and the task environment will be scaled based on individual progress across the intervention period. Exploration of movement and error-based motor learning will also be emphasized. | Behavioural | Gait Training Group |
Primary outcome
MEG Neuroimaging
Time frame: Weekly until 8 weeks
Participants will complete 3 tasks that will be used to quantify the neuroplastic changes in the brain areas that are involved in the control of a leg motor action, processing of somatosensory information and processing of basic visual information. The activity of the brain areas that are involved in the planning and generation of a leg motor action will be assessed with a visually cued task where the participant extends their right knee every time the cue is seen. The activity of the brain areas that process sensory information will be assessed with a paired-pulse, unilateral electrical stimulation that will be applied using electrodes that will be affixed to the skin overlying the right tibial nerve (DS7R; Digitimer, UK). The intensity of stimulation will be set to level that generates a subtle twitch in the toes. The activity of the brain areas that process basic visual information will be assessed by having the participant view a flickering dot on a screen.
10-meter walk
Time frame: Weekly until 8 weeks
Each participant's 10-meter preferred, and fast-as-possible walking speeds will be evaluated. Three trials will be completed at each speed, and the fastest of the respective trials will be the key metric. The respective assessments will occur on a digital mat (ProtoKinetics, Havertown PA) that will quantify the spatiotemporal gait kinematics.
Timed up and go
Time frame: Weekly until 8 weeks
This is a standard clinical test that is used to assess mobility and dynamic balance. The participant will start the test by sitting on a bench. The time 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.
1-minute Walk
Time frame: Weekly until 8 weeks
Cones that are separated by 12.8 meters will be placed on opposite ends of the clinic and the participant is asked to complete laps around the cones as fast-as-possible.
5 secondary outcomes
Sleep/Activity Monitoring
Time frame: Daily until 8 weeks
Pittsburg Sleep Quality Index (PSQI)
Time frame: Weekly until 8 weeks
Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) Survey
Time frame: Weekly until 8 weeks
Secondary Hormone measure
Time frame: Daily until 8 weeks
Daily Menstrual Distress Questionnaire
Time frame: Daily until 8 weeks
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 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy Gait Training in people with Cerebral Palsy (CP), 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 1 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 7 Aug 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?
MEG Neuroimaging (time frame: Weekly until 8 weeks). The study lists 4 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 7 Aug 2026.