Reinforcing CP Robotic Training With Auditory Feedback

Study Overview
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Brief Summary
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The purpose of this study is to create a platform to prolong the adaption obtained from the cable-actuated gait training and encourage the individuals with CP to provide self-care at home.

Detailed Description
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The experiment protocol involves a maximum of ten sessions and will take two or three hours for each session. Baseline data will be collected before the first session for both overground and treadmill walking. During this session, the sound level will be adjusted based on the feedback received from the users. The researcher will ask the comfortable sound level to the participant before starting the experiment. Training will be conducted on the treadmill with the cable-actuated device for about 20 minutes. When the cables were removed, participants walked on the treadmill for 4 minutes during the post-training session. During training and post-training, participants will be exposed to feedback while walking on the treadmill. After treadmill walking, CP participants will be asked to take a ten-minute break and then practice overground walking for two minutes with auditory feedback (type A) and without it (type B). Effects of 3 different types of auditory feedback will be explored namely, rhythmic sounds, movement sonification, and sound notifying erroneous gait. Group A participants will be further divided into groups depending on the type of auditory feedback that will be provided. Participants will participate in a maximum of 10 sessions, two or three times a week. Before the first and after the last training, participants will be evaluated for functional gait assessment, 6-min-walk, leg strength using a dynamometer, and Modified Ashworth test by a physical therapist.

Official Title
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Reinforcing CP Robotic Training With Auditory Feedback

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Bodyweight augment system
* Device: Smart insole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with cerebral palsy (18-65 years old) Ambulation of a distance of 100 feet with or without the use of assistive devices. Exclusion Criteria: Severe Equinovarus foot or Genu recurvatum of the knee Surgery within 6 months will be excluded. Individuals with pregnancy Lower limb prosthetics Severe respiratory problems such as chronic obstructive pulmonary disease, heart disease, a loss of sensation, uncontrolled blood pressure, Seizure disorder Severe arthritis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults with Cerebral Palsy<br>Adults with Cerebral Palsy who are able to be self-ambulatory for minimum 100 feet | Device: Bodyweight augment system<br>* Motorized cables will be providing downward force on the participant's pelvis<br>Device: Smart insole<br>* Insole provided auditory feedback when heel strike or toe-off events happen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of 10m walk between pre/post evaluation and 6 Training sessions | Timing in seconds during 10 m over ground walking. Lower score means faster (better) walking speed | through study completion, an average of 5 weeks | 
| Change of 6 min walk between Pre/post evaluation | Measure distance in meter over 6 min walk. Increased distance shows better walking endurance | through study completion, an average of 5 weeks | 
| Change of Ground reaction force between 6 Training sessions | Bertec Force instrumented treadmill will use to measure vertical ground reaction force in Newton. We will identify whether we can see a distict heel strike and strong push | through study completion, an average of 5 weeks | 
| Change of Kinematics between Pre/post evaluation and 6 Training sessions | Motion capture data. We will measure hip, knee, and ankle joint angles in degrees. We expect to see If the knees is more extended and dorsiflexion is observed at heel strike the gait is improved | through study completion, an average of 5 weeks | 
| Change of surface electromyography between Pre/post evaluation and 6 Training sessions | Surface electromyography will be measured for the lower limb. Unit is in mV. We are expecting to measure the peak semg during each gait cycle. | through study completion, an average of 5 weeks |