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

Overview

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.

Interventions

• 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

Primary outcome measures

• MEG Neuroimaging [Time frame: Weekly until 8 weeks]
• 10-meter walk [Time frame: Weekly until 8 weeks]
• Timed up and go [Time frame: Weekly until 8 weeks]
• 1-minute Walk [Time frame: Weekly until 8 weeks]

Secondary outcome measures (5)

• 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]

Eligibility criteria

Inclusion criteria

Persons with a diagnosis of cerebral palsy.

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Boys Town National Research Hospital — Omaha

Identifiers

NCT: NCT07752030 · IRB#26-029

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗