Clinical trial NCT05335798: Reinforcing CP Robotic Training With Auditory Feedback
Official title: Reinforcing CP Robotic Training With Auditory Feedback
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of 10m walk between pre/post evaluation and 6 Training sessions
timeFrame: through study completion, an average of 5 weeks
measure: Change of 6 min walk between Pre/post evaluation
timeFrame: through study completion, an average of 5 weeks
measure: Change of Ground reaction force between 6 Training sessions
timeFrame: through study completion, an average of 5 weeks
measure: Change of Kinematics between Pre/post evaluation and 6 Training sessions
timeFrame: through study completion, an average of 5 weeks
measure: Change of surface electromyography between Pre/post evaluation and 6 Training sessions
timeFrame: through study completion, an average of 5 weeks
Secondary outcomes:
Other outcomes:
measure: Change of Muscle tone between Pre/post evaluation
timeFrame: through study completion, an average of 5 weeks
measure: Usability questionnaire of Post evaluation
timeFrame: through study completion, an average of 5 weeks
measure: Exit interview after completion of the sessions of Post evaluation
timeFrame: through study completion, an average of 5 weeks
measure: Change of strength of Post evaluation between Pre/post evaluation
timeFrame: through study completion, an average of 5 weeks
measure: Change of functional gait assessment between Pre/post evaluation
timeFrame: through study completion, an average of 5 weeks
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, South Campus, Kimball 115
state: New York
Study officials:
affiliation: University at Buffalo
name: Jiyeon Kang
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.