Gait Adaptation and Biofeedback for Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899153
• Other study ID #: STUDY00015348
• Secondary ID: R01NS091056
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: January 2029

Study information

• Verified date: February 2024
• Source: University of Washington
• Contact: Katherine M Steele, PhD
• Phone: 206-685-2390
• Email: kmsteele[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 repeated training can improve adaptation rates; and third, to determine if individual differences in adaptation relate to improvements in walking function after training. This research will help develop better treatments to enhance walking capacity and performance for children with CP.

Description:

Prior research has shown that children with cerebral palsy (CP) use simplified motor control strategies compared to nondisabled (ND) peers, and that these differences in motor control are associated with walking function. While we can quantify motor control during activities like walking, the processes by which a child with CP adapts and learns new movement patterns are poorly understood.

This research will use two paradigms to evaluate adaptation and motor learning in children with CP: walking on a split-belt treadmill and responding to multimodal biofeedback. Walking on a split-belt treadmill, which has two belts set at different speeds to induce asymmetry during walking, has been commonly used to evaluate adaptation in other clinical populations. Responding to multimodal feedback can also be used to evaluate an individual's capacity to adapt their walking pattern. This research will use a real-time multimodal feedback system that targets plantarflexor activity, a key muscle group that is often impaired in CP. Sensorimotor feedback will be provided using a lightweight, body-worn robotic device that provides adaptive ankle resistance and step-by-step audiovisual feedback will be provided based on muscle activity from the plantarflexors using a visual display and audible tone. This research will quantify adaptation rate (e.g., change in soleus activity or step length symmetry) in response to these perturbations, and observe the impact of repeated practice on walking function (e.g., change in walking speed). The specific aims are to:

Aim-1: Quantify adaptation rates in children with CP. We will quantify adaptation rate in response to three perturbation experiments: split-belt treadmill walking, sensorimotor feedback, and audiovisual feedback. The primary hypotheses are that children with CP will exhibit reduced adaptation rates compared to ND peers, and that adaptation rates will be associated with function (Gross Motor Function Measure, GMFM-66).

Aim-2: Determine whether adaptation rates change in response to repeated feedback training. Children with CP will be randomized into three groups: sensorimotor feedback, audiovisual feedback, and sensorimotor and audiovisual feedback. Each group will undergo six weeks of training (20-min, 2x/week). The primary hypothesis is that adaptation rates will increase with repeated exposures to feedback training.

Aim-3: Determine whether walking function improves after repeated practice. Gait analysis will be performed at follow-up to evaluate whether feedback training induced motor learning and improved walking function. The primary hypotheses are that training will improve muscle, joint, and whole-body performance, with the greatest improvements from combined sensorimotor and audiovisual feedback.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 2029
• Est. primary completion date: May 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of bilateral cerebral palsy that impacts both legs

• Gross Motor Functional Classification System Level II

• No surgery or lower-extremity injuries in prior 12 months

• 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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Gillette Children's	Saint Paul	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Gillette Children's Specialty Healthcare, National Institute of Neurological Disorders and Stroke (NINDS), Northern Arizona University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at 1-month after intervention.
Primary	Change in Peak Ankle Power	Average peak ankle power evaluated during gait.	Change from baseline at 1-month after intervention.
Primary	Change in Self-Selected Walking Speed	Average overground walking speed.	Change from baseline at 1-month after intervention.
Primary	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 at 1-month after intervention.
Primary	Change in Gait Deviation Index (GDI)	Deviation in gait kinematics compared to nondisabled gait.	Change from baseline at 1-month after intervention.
Primary	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 at 1-month after intervention.