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ACTIVE NOT RECRUITING
NCT04360395
NA

Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy

Sponsor: Father Flanagan's Boys' Home

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

13 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2020-08-03

Completion Date

2026-05-31

Last Updated

2025-09-29

Healthy Volunteers

Yes

Conditions

Interventions

BEHAVIORAL

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.

Locations (1)

Boys Town National Research Hospital

Boys Town, Nebraska, United States