Reinforcing CP Robotic Training With Auditory Feedback

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Bodyweight augment system; Device: Smart insole

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14260-4200
      • University at Buffalo, South Campus, Kimball 115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Muscle tone between Pre/post evaluation	Modified Ashworth Scale a clinical measure of muscle spasticity. Rated from 0(no increase in muscle tone) to 4(affected part rigid in flexion or extension). Lower score means better muscle tone.	through study completion, an average of 5 weeks
Usability questionnaire of Post evaluation	Questionnaires were made to understand the the perceived improvement (increased steps and walking speed ) or dose of the intervention (more session and frequency of the intervention). It is rated from 1 very likely to 5 unlikely.	through study completion, an average of 5 weeks
Exit interview after completion of the sessions of Post evaluation	This is designed for any improvement of future study design. We will ask questions on potential improvement of the intervention	through study completion, an average of 5 weeks
Change of strength of Post evaluation between Pre/post evaluation	Measure the strength with Dynamometer in N. Higher number means stronger limb.	through study completion, an average of 5 weeks
Change of functional gait assessment between Pre/post evaluation	Measure different aspects of gait. It is rated from 0 to 3. Higher score means improved improved walking during gait with level surface, change in speed, gait with head turns, step over obstacle, gait with eyes closed, steps.	through study completion, an average of 5 weeks

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Jiyeon Kang, University at Buffalo

Publications and helpful links

General Publications

• Chen D, Asaeikheybari G, Chen H, Xu W, Huang MC. Ubiquitous Fall Hazard Identification With Smart Insole. IEEE J Biomed Health Inform. 2021 Jul;25(7):2768-2776. doi: 10.1109/JBHI.2020.3046701. Epub 2021 Jul 27.
• Kang J, Martelli D, Vashista V, Martinez-Hernandez I, Kim H, Agrawal SK. Robot-driven downward pelvic pull to improve crouch gait in children with cerebral palsy. Sci Robot. 2017 Jul 26;2(8):eaan2634. doi: 10.1126/scirobotics.aan2634. Epub 2017 Jul 26.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): December 5, 2024
• Study Completion (Actual): December 7, 2024

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: STUDY00005147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified data will be shared upon request to PI.
• IPD Sharing Time Frame: After the study is completed
• IPD Sharing Access Criteria: The personnel who is requesting the data needs to explain how the data will be used in their research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No