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Gait Adaptation and Biofeedback for Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biomotum Spark: Robotic ankle resistance
Audiovisual Biofeedback
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Palsy focused on measuring Gait, Rehabilitation

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gillette Children's

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Audiovisual Biofeedback

Sensorimotor Biofeedback

Audiovisual + Sensorimotor Biofeedback

Arm Description

Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving audiovisual biofeedback based on the muscle activity of their ankle plantarflexors. 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.

Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving sensorimotor biofeedback with an ankle exoskeleton that provides resistance to ankle plantarflexion during the stance phase of gait.

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.

Outcomes

Primary Outcome Measures

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 in Peak Ankle Power
Average peak ankle power evaluated during gait.
Change in Self-Selected Walking Speed
Average overground walking speed.
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 in Gait Deviation Index (GDI)
Deviation in gait kinematics compared to nondisabled gait.
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.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2023
Last Updated
October 23, 2023
Sponsor
University of Washington
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Gillette Children's Specialty Healthcare, Northern Arizona University
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1. Study Identification

Unique Protocol Identification Number
NCT05899153
Brief Title
Gait Adaptation and Biofeedback for Cerebral Palsy
Official Title
Quantifying Patient-specific Changes in Neuromuscular Control in Cerebral Palsy: Adaptation and Biofeedback During Gait
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
May 2028 (Anticipated)
Study Completion Date
January 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Gillette Children's Specialty Healthcare, Northern Arizona University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Gait, Rehabilitation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Audiovisual Biofeedback
Arm Type
Experimental
Arm Description
Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving audiovisual biofeedback based on the muscle activity of their ankle plantarflexors. 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.
Arm Title
Sensorimotor Biofeedback
Arm Type
Experimental
Arm Description
Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving sensorimotor biofeedback with an ankle exoskeleton that provides resistance to ankle plantarflexion during the stance phase of gait.
Arm Title
Audiovisual + Sensorimotor Biofeedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Biomotum Spark: Robotic ankle resistance
Intervention Description
Robotic ankle exoskeleton that provides resistance to ankle plantarflexion.
Intervention Type
Device
Intervention Name(s)
Audiovisual Biofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Soleus Muscle Activity
Description
Average stance-phase magnitude of soleus muscle activity from electromyography recording measured during gait at 1-month follow-up.
Time Frame
Change from baseline at 1-month after intervention.
Title
Change in Peak Ankle Power
Description
Average peak ankle power evaluated during gait.
Time Frame
Change from baseline at 1-month after intervention.
Title
Change in Self-Selected Walking Speed
Description
Average overground walking speed.
Time Frame
Change from baseline at 1-month after intervention.
Title
Change in Dynamic Motor Control During Walking (Walk-DMC)
Description
The total variance account for by one muscle synergy calculated from electromyography recordings during gait.
Time Frame
Change from baseline at 1-month after intervention.
Title
Change in Gait Deviation Index (GDI)
Description
Deviation in gait kinematics compared to nondisabled gait.
Time Frame
Change from baseline at 1-month after intervention.
Title
Change in Gross Motor Function Measure - 66 (GMFM-66) Parts D & E
Description
Assessment tool designed and evaluated to measure changes in gross motor function. Parts D & E focus on standing, walking, jumping, and running function.
Time Frame
Change from baseline at 1-month after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine M Steele, PhD
Phone
206-685-2390
Email
kmsteele@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Spomer, PhD
Email
AlyssaMSpomer@gillettechildrens.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine M Steele, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gillette Children's
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Spomer, PhD
Phone
651-229-3904
Email
AlyssaMSpomer@gillettechildrens.com
First Name & Middle Initial & Last Name & Degree
Michael H Schwartz, PhD
Email
MSchwartz@gillettechildrens.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data from gait analysis and outcome measures will be provided on a public data repository.
IPD Sharing Time Frame
Data will be made available within one year after completion of data collection.

Learn more about this trial

Gait Adaptation and Biofeedback for Cerebral Palsy

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