Gait Adaptation and Biofeedback for Cerebral Palsy

NCT05899153 | Recruiting FDA Device

• 2 other identifiers: STUDY00015348R01NS091056
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

Gait; Rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Orthopedic Surgery

EXPERIMENTAL

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

Audiovisual + Sensorimotor Biofeedback

EXPERIMENTAL

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: Biomotum Spark: Robotic ankle resistance; Device: Audiovisual Biofeedback

Interventions

Biomotum Spark: Robotic ankle resistance DEVICE

Robotic ankle exoskeleton that provides resistance to ankle plantarflexion.

Audiovisual + Sensorimotor Biofeedback

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.

Audiovisual + Sensorimotor Biofeedback

Multilevel Orthopedic Surgery PROCEDURE

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.

Orthopedic Surgery

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Gillette Children's Specialty Healthcare: collaborator
• Northern Arizona University: collaborator

Study Sites (1)

Gillette Children's

Saint Paul, Minnesota, 55101, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Katherine M Steele, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine M Steele, PhD

CONTACT

206-685-2390; kmsteele@uw.edu

Alyssa Spomer, PhD

CONTACT

AlyssaMSpomer@gillettechildrens.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Mechanical Engineering

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 12, 2023
• Study Start: November 28, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available within one year after completion of data collection.

Locations

US (1)