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Reinforcing CP Robotic Training With Auditory Feedback

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05335798
Recruitment Status : Recruiting
First Posted : April 19, 2022
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Jiyeon Kang, State University of New York at Buffalo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: Bodyweight augment system Device: Smart insole Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reinforcing CP Robotic Training With Auditory Feedback
Actual Study Start Date : December 7, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change of 10m walk between pre/post evaluation and 6 Training sessions [ Time Frame: through study completion, an average of 5 weeks ]
    Timing in seconds during 10 m over ground walking. Lower score means faster (better) walking speed

  2. Change of 6 min walk between Pre/post evaluation [ Time Frame: through study completion, an average of 5 weeks ]
    Measure distance in meter over 6 min walk. Increased distance shows better walking endurance

  3. Change of Ground reaction force between 6 Training sessions [ Time Frame: through study completion, an average of 5 weeks ]
    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

  4. Change of Kinematics between Pre/post evaluation and 6 Training sessions [ Time Frame: through study completion, an average of 5 weeks ]
    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

  5. Change of surface electromyography between Pre/post evaluation and 6 Training sessions [ Time Frame: through study completion, an average of 5 weeks ]
    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.


Other Outcome Measures:
  1. Change of Muscle tone between Pre/post evaluation [ Time Frame: through study completion, an average of 5 weeks ]
    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.

  2. Usability questionnaire of Post evaluation [ Time Frame: through study completion, an average of 5 weeks ]
    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.

  3. Exit interview after completion of the sessions of Post evaluation [ Time Frame: through study completion, an average of 5 weeks ]
    This is designed for any improvement of future study design. We will ask questions on potential improvement of the intervention

  4. Change of strength of Post evaluation between Pre/post evaluation [ Time Frame: through study completion, an average of 5 weeks ]
    Measure the strength with Dynamometer in N. Higher number means stronger limb.

  5. Change of functional gait assessment between Pre/post evaluation [ Time Frame: through study completion, an average of 5 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05335798


Contacts
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Contact: Jiyeon Kang 7166456063 jiyeonk@buffalo.edu

Locations
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United States, New York
University at Buffalo, South Campus, Kimball 115 Recruiting
Buffalo, New York, United States, 14260-4200
Contact: Jiyeon Kang    716-645-6063    jiyeonk@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
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Principal Investigator: Jiyeon Kang University at Buffalo
  Study Documents (Full-Text)

Documents provided by Jiyeon Kang, State University of New York at Buffalo:
Study Protocol and Statistical Analysis Plan  [PDF] March 7, 2022
Informed Consent Form  [PDF] March 7, 2022

More Information
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Publications of Results:

Other Publications:

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Responsible Party: Jiyeon Kang, Assistant Professor, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT05335798    
Other Study ID Numbers: STUDY00005147
First Posted: April 19, 2022    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified data will be shared upon request to PI.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases