Reinforcing CP Robotic Training With Auditory Feedback

NCT ID: NCT05335798

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2024-12-07

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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adults with Cerebral Palsy

Adults with Cerebral Palsy who are able to be self-ambulatory for minimum 100 feet

Group Type EXPERIMENTAL

Bodyweight augment system

Intervention Type DEVICE

Motorized cables will be providing downward force on the participant's pelvis

Smart insole

Intervention Type DEVICE

Insole provided auditory feedback when heel strike or toe-off events happen

Interventions

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Bodyweight augment system

Motorized cables will be providing downward force on the participant's pelvis

Intervention Type DEVICE

Smart insole

Insole provided auditory feedback when heel strike or toe-off events happen

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Jiyeon Kang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiyeon Kang

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

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University at Buffalo, South Campus, Kimball 115

Buffalo, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33351772 (View on PubMed)

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.

Reference Type RESULT
PMID: 33157884 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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STUDY00005147

Identifier Type: -

Identifier Source: org_study_id

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