Sampling Therapeutic Effects and Progress in Cerebral Palsy (STEP-CP)

NCT07752030 | Enrolling By Invitation

• 1 other identifier: IRB#26-029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cerebral Palsy (CP)

Keywords

Physical Therapy; Exercise; brain imaging; hormones

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Weekly until 8 weeks

Secondary Outcomes (5)

• Sleep/Activity Monitoring

  Daily until 8 weeks

• Pittsburg Sleep Quality Index (PSQI)

  Weekly until 8 weeks

• Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) Survey

  Weekly until 8 weeks

• Secondary Hormone measure

  Daily until 8 weeks

• Daily Menstrual Distress Questionnaire

  Daily until 8 weeks

Study Arms (1)

Gait Training Group

EXPERIMENTAL

Participants receive a goal-directed gait training intervention

Behavioral: Physical Therapy Gait Training

Interventions

Physical Therapy Gait Training BEHAVIORAL

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.

Gait Training Group

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Persons with a diagnosis of cerebral palsy.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Father Flanagan's Boys' Home: lead

Study Sites (1)

Boys Town National Research Hospital

Omaha, Nebraska, 68010, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of PoWER Lab

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 7, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)