An interventional study of Physical Therapy Gait Training in Cerebral Palsy (CP), sponsored by Father Flanagan's Boys' Home. Enrolling by invitation at 1 site in United States. Open to participants aged 16 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Father Flanagan's Boys' Home · Not applicable, Interventional, and Treatment
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.
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 20 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Father Flanagan's Boys' Home is the lead sponsor of 19 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Persons with a diagnosis of cerebral palsy.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a goal-directed gait training intervention
Behavioral: Physical Therapy Gait Training
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weekly until 8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Daily until 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jun 2028, 22 months later.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 22 months is above that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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