NCT05899153 · University of Washington
Gait Adaptation and Biofeedback for Cerebral Palsy
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Biomotum Spark: Robotic ankle resistance
Robotic ankle exoskeleton that provides resistance to ankle plantarflexion.
DEVICE
Audiovisual Biofeedback
Electromyography 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.
PROCEDURE
Multilevel Orthopedic Surgery
Musculoskeletal 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.
Primary outcome measures
Change in Soleus Muscle Activity
Time frame: Change from baseline to intervention follow-up, assessed up to 18 months
Average stance-phase magnitude of soleus muscle activity from electromyography recording measured during gait at 1-month follow-up.
Change in Peak Ankle Power
Time frame: Change from baseline to intervention follow-up, assessed up to 18 months
Average peak ankle power evaluated during gait.
Change in Self-Selected Walking Speed
Time frame: Change from baseline after intervention.
Average overground walking speed.
Change in Dynamic Motor Control During Walking (Walk-DMC)
Time frame: Change from baseline to intervention follow-up, assessed up to 18 months
The total variance account for by one muscle synergy calculated from electromyography recordings during gait.
Change in Gait Deviation Index (GDI)
Time frame: Change from baseline to intervention follow-up, assessed up to 18 months
Deviation in gait kinematics compared to nondisabled gait.
Change in Gross Motor Function Measure - 66 (GMFM-66) Parts D & E
Time frame: Change from baseline to intervention follow-up, assessed up to 18 months
Assessment tool designed and evaluated to measure changes in gross motor function. Parts D \& E focus on standing, walking, jumping, and running function.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- No prior selective dorsal rhizotomy surgery
- No history of seizures or cardiac conditions that would preclude walking on a treadmill for 20 minutes
- No current pain that hinders walking
Where
- Saint Paul, Minnesota
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Gillette Children's Specialty Healthcare, Northern Arizona University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations