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Reinforcing CP Robotic Training With Auditory Feedback

Primary Purpose

Cerebral Palsy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bodyweight augment system
Smart insole
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University at Buffalo, South Campus, Kimball 115

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adults with Cerebral Palsy

Arm Description

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

Outcomes

Primary Outcome Measures

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
Change of 6 min walk between Pre/post evaluation
Measure distance in meter over 6 min walk. Increased distance shows better walking endurance
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2022
Last Updated
August 27, 2023
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT05335798
Brief Title
Reinforcing CP Robotic Training With Auditory Feedback
Official Title
Reinforcing CP Robotic Training With Auditory Feedback
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
December 5, 2024 (Anticipated)
Study Completion Date
December 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adults with Cerebral Palsy
Arm Type
Experimental
Arm Description
Adults with Cerebral Palsy who are able to be self-ambulatory for minimum 100 feet
Intervention Type
Device
Intervention Name(s)
Bodyweight augment system
Intervention Description
Motorized cables will be providing downward force on the participant's pelvis
Intervention Type
Device
Intervention Name(s)
Smart insole
Intervention Description
Insole provided auditory feedback when heel strike or toe-off events happen
Primary Outcome Measure Information:
Title
Change of 10m walk between pre/post evaluation and 6 Training sessions
Description
Timing in seconds during 10 m over ground walking. Lower score means faster (better) walking speed
Time Frame
through study completion, an average of 5 weeks
Title
Change of 6 min walk between Pre/post evaluation
Description
Measure distance in meter over 6 min walk. Increased distance shows better walking endurance
Time Frame
through study completion, an average of 5 weeks
Title
Change of Ground reaction force between 6 Training sessions
Description
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
Time Frame
through study completion, an average of 5 weeks
Title
Change of Kinematics between Pre/post evaluation and 6 Training sessions
Description
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
Time Frame
through study completion, an average of 5 weeks
Title
Change of surface electromyography between Pre/post evaluation and 6 Training sessions
Description
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.
Time Frame
through study completion, an average of 5 weeks
Other Pre-specified Outcome Measures:
Title
Change of Muscle tone between Pre/post evaluation
Description
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.
Time Frame
through study completion, an average of 5 weeks
Title
Usability questionnaire of Post evaluation
Description
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.
Time Frame
through study completion, an average of 5 weeks
Title
Exit interview after completion of the sessions of Post evaluation
Description
This is designed for any improvement of future study design. We will ask questions on potential improvement of the intervention
Time Frame
through study completion, an average of 5 weeks
Title
Change of strength of Post evaluation between Pre/post evaluation
Description
Measure the strength with Dynamometer in N. Higher number means stronger limb.
Time Frame
through study completion, an average of 5 weeks
Title
Change of functional gait assessment between Pre/post evaluation
Description
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.
Time Frame
through study completion, an average of 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiyeon Kang
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo, South Campus, Kimball 115
City
Buffalo
State/Province
New York
ZIP/Postal Code
14260-4200
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33351772
Citation
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.
Results Reference
background
PubMed Identifier
33157884
Citation
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.
Results Reference
result

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Reinforcing CP Robotic Training With Auditory Feedback

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