About this trial
This research aims to evaluate walking function in children with cerebral palsy (CP). The researchers want to understand how children with CP adapt and learn new ways of moving. They have previously found that measuring how a person controls their muscles is important for assessing walking ability and response to interventions. In these studies, they will adjust the treadmill belt speeds and/or provide real-time feedback to evaluate how a child can alter their movement. The feedback will include a wearable exoskeleton that provides resistance to the ankle and audio and visual cues based on sensors that record muscle activity. This research will investigate three goals: first, to measure how children with CP adapt their walking; second, to see if either repeated training or orthopedic surgery can improve adaptation rates; and third, to determine if individual differences in adaptation relate to improvements in walking function after treatment. This research will help develop better treatments to enhance walking capacity and performance for children with CP.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosis of bilateral cerebral palsy that impacts both legs
Gross Motor Functional Classification System Level II
No surgery or lower-extremity injuries 12 months prior to enrollment
No botulinum toxin injections in prior 3 months
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Biomotum Spark: Robotic ankle resistance
DeviceRobotic ankle exoskeleton that provides resistance to ankle plantarflexion.
Audiovisual Biofeedback
DeviceElectromyography recordings from the plantarflexor muscles are used to provide audio feedback via a sound that plays when muscle activity is above target and a visual bar that displays real-time muscle activity.
Multilevel Orthopedic Surgery
Procedure/SurgeryMusculoskeletal surgeries to address alignment, contracture, and other lower-extremity impairments. This study does not impact surgical decision making but evaluates changes in gait before and after surgery.
Treatment groups
Trial outcomes
Primary outcomes
Change in Soleus Muscle Activity
Average stance-phase magnitude of soleus muscle activity from electromyography recording measured during gait at 1-month follow-up.
Change in Peak Ankle Power
Average peak ankle power evaluated during gait.
Change in Self-Selected Walking Speed
Average overground walking speed.
Change in Dynamic Motor Control During Walking (Walk-DMC)
The total variance account for by one muscle synergy calculated from electromyography recordings during gait.
Sponsors and contacts
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University of Washington
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Gillette Children's Specialty Healthcare
Collaborator
Northern Arizona University
Collaborator