Gait Adaptation and Biofeedback for Cerebral Palsy

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
University of Washington
Study ID
NCT05899153
Status
Recruiting
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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
7 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Biomotum Spark: Robotic ankle resistance — DEVICE
    Robotic ankle exoskeleton that provides resistance to ankle plantarflexion.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 28, 2023
Status verified
Jun 2026
Primary completion
May 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Change in Soleus Muscle Activity [ Time Frame: Change from baseline to intervention follow-up, assessed up to 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Gillette Children'sSaint PaulMinnesota55101
Alyssa Spomer, PhD
[email protected]
651-229-3904
Michael H Schwartz, PhD
[email protected]

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By research site
Gillette Children's· Saint Paul, MN

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