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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Minnesota
Gillette Children's
RECRUITING
Saint Paul
Contact Information
Primary
Katherine M Steele, PhD
kmsteele@uw.edu
206-685-2390
Backup
Alyssa Spomer, PhD
AlyssaMSpomer@gillettechildrens.com
Time Frame
Start Date: 2023-11-28
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 36
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Northern Arizona University, Gillette Children's Specialty Healthcare, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: University of Washington

This content was sourced from clinicaltrials.gov