Gait Adaptation and Biofeedback for Cerebral Palsy

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

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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Gillette Children's Specialty Healthcare

  collaborator OTHER

• Northern Arizona University

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Katherine M Steele, PhD · University of Washington

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-28

Primary Completion

2028-05-01

Completion

2029-01-01

FDA Device

Yes

Countries

• United States

Study Locations