Gait Adaptation and Biofeedback for Cerebral Palsy

This study is looking at how children with cerebral palsy (CP) learn and adapt their walking patterns. Researchers will use a special robotic ankle device called Biomotum Spark, which provides resistance to the ankle, along with audiovisual biofeedback. This feedback uses sounds and visual displays based on your muscle activity to help you learn new ways of moving. The study will also look at changes in walking before and after Multilevel Orthopedic Surgery, though it doesn't affect surgical decisions. The goal is to see how these interventions change your soleus muscle activity, ankle power, and walking speed over up to 18 months. You may be able to join if you are 7 to 18 years old, have bilateral CP affecting both legs, and meet other health criteria. The study is currently unclear on its recruitment status and plans to enroll 36 participants.

Study design
This interventional study plans to enroll 36 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in walking function for up to 18 months after the intervention.

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NCT05899153

Gait Adaptation and Biofeedback for Cerebral Palsy

Recruiting
NAAges 7–18InterventionalBasic science
University of Washington
~36 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Biomotum Spark: Robotic ankle resistanceAudiovisual BiofeedbackMultilevel Orthopedic Surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Soleus Muscle Activity
Measured over Change from baseline to intervention follow-up, assessed up to 18 months
+5 more outcomes measured
Cerebral Palsy
1 sites across 1 states
Minnesota1
  • Katherine M Steele, PhD · PRINCIPAL_INVESTIGATOR · University of Washington

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Eligibility criteria

Inclusion

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
  • Change in Soleus Muscle ActivityChange 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 PowerChange from baseline to intervention follow-up, assessed up to 18 months

    Average peak ankle power evaluated during gait.

  • Change in Self-Selected Walking SpeedChange from baseline after intervention.

    Average overground walking speed.

  • Change in Dynamic Motor Control During Walking (Walk-DMC)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)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 & EChange 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.