Reinforcing CP Robotic Training With Auditory Feedback

Cerebral Palsy Clinical Trial

Official title:

Reinforcing CP Robotic Training With Auditory Feedback

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05335798
• Other study ID #: STUDY00005147
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 7, 2021
• Est. completion date: December 7, 2024

Study information

• Verified date: August 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: December 7, 2024
• Est. primary completion date: December 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Bodyweight augment system
Motorized cables will be providing downward force on the participant's pelvis
• Smart insole
Insole provided auditory feedback when heel strike or toe-off events happen

Locations

Country	Name	City	State
United States	University at Buffalo, South Campus, Kimball 115	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Muscle tone between Pre/post evaluation	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.	through study completion, an average of 5 weeks
Other	Usability questionnaire of Post evaluation	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.	through study completion, an average of 5 weeks
Other	Exit interview after completion of the sessions of Post evaluation	This is designed for any improvement of future study design. We will ask questions on potential improvement of the intervention	through study completion, an average of 5 weeks
Other	Change of strength of Post evaluation between Pre/post evaluation	Measure the strength with Dynamometer in N. Higher number means stronger limb.	through study completion, an average of 5 weeks
Other	Change of functional gait assessment between Pre/post evaluation	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.	through study completion, an average of 5 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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