Gait Adaptation and Biofeedback for Cerebral Palsy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorUniversity of Washington

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Biomotum Spark: Robotic ankle resistance

    Device

    Robotic ankle exoskeleton that provides resistance to ankle plantarflexion.

  • Audiovisual Biofeedback

    Device

    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.

  • Multilevel Orthopedic Surgery

    Procedure/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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Orthopedic SurgeryExperimental treatment 1 intervention
Group B: Audiovisual + Sensorimotor BiofeedbackExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Soleus Muscle Activity

Average stance-phase magnitude of soleus muscle activity from electromyography recording measured during gait at 1-month follow-up.

Time frame
Change from baseline to intervention follow-up, assessed up to 18 months
2

Change in Peak Ankle Power

Average peak ankle power evaluated during gait.

Time frame
Change from baseline to intervention follow-up, assessed up to 18 months
3

Change in Self-Selected Walking Speed

Average overground walking speed.

Time frame
Change from baseline after intervention.
4

Change in Dynamic Motor Control During Walking (Walk-DMC)

The total variance account for by one muscle synergy calculated from electromyography recordings during gait.

Time frame
Change from baseline to intervention follow-up, assessed up to 18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Gillette Children's Specialty Healthcare

Collaborator

Northern Arizona University

Collaborator