Reinforcing CP Robotic Training With Auditory Feedback

NCT05335798 | Completed

• 1 other identifier: STUDY00005147
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Change of Muscle tone between Pre/post evaluation

  through study completion, an average of 5 weeks

• Usability questionnaire of Post evaluation

  through study completion, an average of 5 weeks

• Exit interview after completion of the sessions of Post evaluation

  through study completion, an average of 5 weeks

Study Arms (1)

Adults with Cerebral Palsy

EXPERIMENTAL

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

Device: Bodyweight augment system; Device: Smart insole

Interventions

Bodyweight augment system DEVICE

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

Adults with Cerebral Palsy

Smart insole DEVICE

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

Adults with Cerebral Palsy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with cerebral palsy (18-65 years old)
• Ambulation of a distance of 100 feet with or without the use of assistive devices.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo, South Campus, Kimball 115

Buffalo, New York, 14260-4200, United States

Location

Related Publications (2)

• 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.

  PMID: 33351772 BACKGROUND

• 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.

  PMID: 33157884 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jiyeon Kang

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 19, 2022
• Study Start: December 7, 2021
• Primary Completion: December 5, 2024
• Study Completion: December 7, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the study is completed
• Access Criteria: The personnel who is requesting the data needs to explain how the data will be used in their research.

Locations

US (1)