Gait Adaptation and Biofeedback for Cerebral Palsy

Quantifying Patient-specific Changes in Neuromuscular Control in Cerebral Palsy: Adaptation and Biofeedback During Gait

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Audiovisual Biofeedback; Device: Biomotum Spark: Robotic ankle resistance; Procedure: Multilevel Orthopedic Surgery

Detailed Description

Prior research has shown that children with cerebral palsy (CP) use simplified motor control strategies compared to nondisabled (ND) peers, and that these differences in motor control are associated with walking function. While we can quantify motor control during activities like walking, the processes by which a child with CP adapts and learns new movement patterns are poorly understood.

This research will use two paradigms to evaluate adaptation and motor learning in children with CP: walking on a split-belt treadmill and responding to multimodal biofeedback. Walking on a split-belt treadmill, which has two belts set at different speeds to induce asymmetry during walking, has been commonly used to evaluate adaptation in other clinical populations. Responding to multimodal feedback can also be used to evaluate an individual's capacity to adapt their walking pattern. This research will use a real-time multimodal feedback system that targets plantarflexor activity, a key muscle group that is often impaired in CP. Sensorimotor feedback will be provided using a lightweight, body-worn robotic device that provides adaptive ankle resistance and step-by-step audiovisual feedback will be provided based on muscle activity from the plantarflexors using a visual display and audible tone. This research will quantify adaptation rate (e.g., change in soleus activity or step length symmetry) in response to these perturbations, and observe the impact of repeated practice or orthopedic surgery on walking function (e.g., change in walking speed). The specific aims are to:

Aim-1: Quantify adaptation rates in children with CP. We will quantify adaptation rate in response to three perturbation experiments: split-belt treadmill walking, sensorimotor feedback, and audiovisual feedback. The primary hypotheses are that children with CP will exhibit reduced adaptation rates compared to ND peers, and that adaptation rates will be associated with function (Gross Motor Function Measure, GMFM-66).

Aim-2: Determine whether adaptation rates change in response to repeated multimodal feedback training. We will evaluate children with CP who undergo six weeks of multimodal biofeedback training (20-min, 2x/week) or orthopedic surgery. The primary hypothesis is that multimodal feedback training will produce greater changes in adaptation rates than orthopedic surgery.

Aim-3: Determine whether changes in gait after treatment are associated with adaptation rates. Gait analysis will be performed to determine whether baseline adaptation rates are associated with changes in gait after treatment. The primary hypotheses are that baseline adaptation rates will be associated with changes in muscle, joint, and whole-body performance.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine M Steele, PhD; Phone Number: 206-685-2390; Email: kmsteele@uw.edu
• Study Contact Backup: Name: Alyssa Spomer, PhD; Email: AlyssaMSpomer@gillettechildrens.com

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Recruiting
      • Gillette Children's
      • Contact: Alyssa Spomer, PhD; Phone Number: 651-229-3904; Email: AlyssaMSpomer@gillettechildrens.com
      • Contact: Michael H Schwartz, PhD; Email: MSchwartz@gillettechildrens.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Audiovisual + Sensorimotor Biofeedback; Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving both audiovisual and sensorimotor biofeedback. Sensorimotor biofeedback will be provided with an ankle exoskeleton that provides resistance to ankle plantarflexion during the stance phase of gait. The visual feedback will be provided on a screen with a bar showing real-time muscle activity and the audio feedback will be a sound played when they reach the target level of muscle activity from the plantarflexors.	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.; Device: Biomotum Spark: Robotic ankle resistance; Robotic ankle exoskeleton that provides resistance to ankle plantarflexion.
Experimental: Orthopedic Surgery; Participants who have been scheduled for lower-extremity, multilevel orthopedic surgery will be assessed before and 9-18 months after surgery to evaluate changes in gait and adaptation rates.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 from baseline to intervention follow-up, assessed up to 18 months
Change in Peak Ankle Power	Average peak ankle power evaluated during gait.	Change from baseline to intervention follow-up, assessed up to 18 months
Change in Self-Selected Walking Speed	Average overground walking speed.	Change from baseline after intervention.
Change in Dynamic Motor Control During Walking (Walk-DMC)	The total variance account for by one muscle synergy calculated from electromyography recordings during gait.	Change from baseline to intervention follow-up, assessed up to 18 months
Change in Gait Deviation Index (GDI)	Deviation in gait kinematics compared to nondisabled gait.	Change from baseline to intervention follow-up, assessed up to 18 months
Change in Gross Motor Function Measure - 66 (GMFM-66) Parts D & E	Assessment tool designed and evaluated to measure changes in gross motor function. Parts D & E focus on standing, walking, jumping, and running function.	Change from baseline to intervention follow-up, assessed up to 18 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Northern Arizona University; Gillette Children's Specialty Healthcare
• Investigators: Principal Investigator: Katherine M Steele, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Gait
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: STUDY00015348; R01NS091056 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data from gait analysis and outcome measures will be provided on a public data repository.
• IPD Sharing Time Frame: Data will be made available within one year after completion of data collection.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No