Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy

NCT ID: NCT04360395

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2026-05-31

Brief Summary

The study design will consist of a cohort of adolescents and young adults with cerebral palsy (CP) that will undergo a gait training protocol. All participants will complete MEG or EEG baseline brain imaging measures of their sensorimotor cortical activity, MRI brain/spinal cord imaging (previous MRI or template brain may be substituted), neurophysiological tests of the spinal cord H-reflex, and a series of mobility clinical tests and cognitive tests. Participants with metal in their body that would interfere with the MEG (e.g., braces on teeth, permanent retainer) will not undergo the MEG tests but will undergo the EEG assessments. Those who complete the MEG assessments will not undergo the EEG assessments.

After completing the baseline tests, the participants with CP will undergo the therapeutic gait training. After completing all of the therapeutic gait training sessions, the participants with CP will repeat the same assessments that were completed at baseline.

Separately, a cohort of neurotypical adolescents and young adults will also complete the baseline assessments. The neurotypical participants will not undergo the therapeutic gait training, but will be used as a normative group for interpreting if the changes seen in the participants with CP after therapy are in fact moving the system toward a normative state.

Detailed Description

Cerebral palsy (CP) results from a perinatal brain injury and is one of the most prevalent and costly pediatric neurologic conditions in the United States that often results in mobility deficits. The investigator's extensive experimental work has been focused on developing a therapeutic gait training protocol that will improve the long-term mobility of adolescents and young adults with CP. Despite the major breakthroughs, it is apparent across the investigations that some patients have vast improvements in their mobility after treatment, while others are clearly non-responders. This response variability represents one of the major Gordian knots in the treatment outcomes seen in adolescents and young adults with CP. The investigator will address this knowledge gap with a multimodal approach that blends the investigator's expertise in MEG/EEG brain imaging, MRI spinal cord imaging, and assessments of the spinal cord interneuronal circuitry to probe the neurophysiological differences in participants that are classified as responders and non-responders after therapeutic gait training. The Specific Aims of this study will: (1) identify if responders and non-responders have differences in the strength of the sensorimotor cortical oscillations involved in the planning and execution of a leg motor action, (2) determine if responders and non-responders have differences in the neural synchrony within the somatosensory cortices, following stimulation of the foot mechanoreceptors, and (3) decipher if responders and non-responders have differences in the spinal cord microstructure and circuitry dynamics. (4) Secondary aim: assess cognitive related changes induced via physical therapy. Briefly, the study design consists of a cohort of adolescents and young adults with CP that will initially undergo MEG/EEG brain imaging, MRI spinal cord imaging, neurophysiological tests of the spinal cord interneuronal circuitry, cognitive testing, and clinical mobility assessments. After completing the baseline tests, the participants will undergo the therapeutic gait training protocol. Upon completion of the treatment program, the participants will repeat the same assessments that were completed at baseline. Separation of the participants into responders and non-responders to treatment will be based on the criteria for a clinically relevant change in the 10-meter walking speed test. The new data derived from this project will provide unparalleled insight on the potential neurophysiological origins of the diverse mobility outcomes seen in adolescents and young adults with CP after treatment. Finally, an additional cohort of neurotypical adolescents and young adults of similar age and sex will also complete the mobility, MEG/EEG, spinal cord imaging, and Hoffmann reflex protocols for comparative purposes.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neurotypical Youth/Young Adults

No intervention administered. The controls will only undergo initial baseline assessments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cerebral Palsy Youth/Young Adults

Baseline and 8 week assessments; 8 week gait therapy

Group Type: EXPERIMENTAL

Gait Therapy

Intervention Type: BEHAVIORAL

The therapeutic gait training protocol will consist of 24-treatment sessions that will be performed 3 times-a-week for an 8-week period. All therapeutic exercises will be performed under the direction of a licensed pediatric physical therapist. Any sessions missed will be added on to the 8-week period. Each intervention session will consist of over-ground gait activities that will be completed in a 60 minute session with rests as needed. The key ingredients of the therapy will include: 1) activities of adequate intensity that promote gait adaptation and gait speed sustainment, 2) exploratory activities that enhance the somatosensory experience through rich/novel movement, and 3) optimally challenging activities that emphasize planning and problem solving that requires altering the leg kinematics to meet the environmental and task constraints.

Interventions

Gait Therapy

The therapeutic gait training protocol will consist of 24-treatment sessions that will be performed 3 times-a-week for an 8-week period. All therapeutic exercises will be performed under the direction of a licensed pediatric physical therapist. Any sessions missed will be added on to the 8-week period. Each intervention session will consist of over-ground gait activities that will be completed in a 60 minute session with rests as needed. The key ingredients of the therapy will include: 1) activities of adequate intensity that promote gait adaptation and gait speed sustainment, 2) exploratory activities that enhance the somatosensory experience through rich/novel movement, and 3) optimally challenging activities that emphasize planning and problem solving that requires altering the leg kinematics to meet the environmental and task constraints.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• For Cerebral Palsy participants:

• Cerebral Palsy diagnosis
• For Non-Cerebral Palsy Controls:

• No known atypical neurodevelopment (e.g autism, Down Syndrome, ADHD, etc.)

Exclusion Criteria

• No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Father Flanagan's Boys' Home

OTHER

Sponsor Role: lead

Responsible Party

Max Kurz

Director of PoWER Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Max J Kurz, PhD

Role: PRINCIPAL_INVESTIGATOR

Father Flanagan's Boys' Home

Locations

Boys Town National Research Hospital

Boys Town, Nebraska, United States

Countries

United States

Other Identifiers

20-24-XP

Identifier Type: -

Identifier Source: org_study_id