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

Conditions

• Cerebral Palsy (CP)

Eligibility Criteria

Sex

ALL

Age

16 Years - 30 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Aug 7, 2026

Start date

Aug 10, 2026

Status verified

Aug 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2030

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Gait Training Group
  Participants receive a goal-directed gait training intervention

Primary Outcome Measure

MEG Neuroimaging [ Time Frame: Weekly until 8 weeks ]

Locations (1)

Find similar trials in Omaha, NE

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