Recruiting

Cerebral Palsy

Sponsor:

University of Washington

Code:

NCT05899153

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Accepted

Interventions

Biomotum Spark: Robotic ankle resistance

Audiovisual Biofeedback

Multilevel Orthopedic Surgery

Study Details

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

Study ID

NCT05899153

Start date

Nov 28, 2023

Status verified date

Jun, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Biomotum Spark: Robotic ankle resistance

Robotic ankle exoskeleton that provides resistance to ankle plantarflexion.

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.

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.

Primary outcome measure

  • Change in Soleus Muscle Activity [ Time Frame: Change from baseline to intervention follow-up, assessed up to 18 months ]
  • Change in Peak Ankle Power [ Time Frame: Change from baseline to intervention follow-up, assessed up to 18 months ]
  • Change in Self-Selected Walking Speed [ Time Frame: Change from baseline after intervention. ]
  • Change in Dynamic Motor Control During Walking (Walk-DMC) [ Time Frame: Change from baseline to intervention follow-up, assessed up to 18 months ]
  • Change in Gait Deviation Index (GDI) [ Time Frame: Change from baseline to intervention follow-up, assessed up to 18 months ]
  • Change in Gross Motor Function Measure - 66 (GMFM-66) Parts D & E [ Time Frame: Change from baseline to intervention follow-up, assessed up to 18 months ]

Central Contacts and Locations

Central contacts

Katherine M Steele, PhD

206-685-2390kmsteele@uw.edu

Alyssa Spomer, PhD

AlyssaMSpomer@gillettechildrens.com

Locations

Gillette Children's

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Alyssa Spomer, PhD

651-229-3904AlyssaMSpomer@gillettechildrens.com

Michael H Schwartz, PhD

MSchwartz@gillettechildrens.com

More Information

Sponsor

University of Washington

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Gait
  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-06-08.