Cerebral PalsyNCT05335798
Reinforcing CP Robotic Training With Auditory Feedback
A study testing Bodyweight augment system and Smart insole in people with Cerebral Palsy, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Bodyweight augment system and Smart insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 7 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with cerebral palsy (18-65 years old)
- Ambulation of a distance of 100 feet with or without the use of assistive devices.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University at Buffalo, South Campus, Kimball 115
Buffalo, New York, 14260-4200
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Bodyweight augment system, Smart insole
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodyweight augment systemDevice
Motorized cables will be providing downward force on the participant's pelvis
Smart insoleDevice
Insole provided auditory feedback when heel strike or toe-off events happen
| Study group | Role | What they receive |
|---|---|---|
| Adults with Cerebral Palsy | Experimental | Adults with Cerebral Palsy who are able to be self-ambulatory for minimum 100 feet Receives: Device: Bodyweight augment system; Device: Smart insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: through study completion, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start7 Dec 2021
- Primary completion5 Dec 2024
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyeon Kang, State University of New York at Buffalo
- Investigators
- Jiyeon Kang, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335798
- Sponsor's protocol ID
- STUDY00005147
- Status last verified
- Nov 2025
- First submitted
- 11 Mar 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data will be shared upon request to PI.
Publications
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.
PubMed 33351772Kang 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.
PubMed 33157884
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reinforcing CP Robotic Training With Auditory Feedback
- ClinicalTrials.gov ID
- NCT05335798
- Acronym / sponsor ID
- STUDY00005147
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Cerebral Palsy | Experimental | Device: Bodyweight augment system, Device: Smart insoleAdults with Cerebral Palsy who are able to be self-ambulatory for minimum 100 feet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with cerebral palsy (18-65 years old)
- Ambulation of a distance of 100 feet with or without the use of assistive devices.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bodyweight augment systemMotorized cables will be providing downward force on the participant's pelvis | Device | Adults with Cerebral Palsy |
| Smart insoleInsole provided auditory feedback when heel strike or toe-off events happen | Device | Adults with Cerebral Palsy |
Primary outcome
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
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 33351772Chen 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 publication: PubMed 33157884Kang 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.
- Individual participant dataSharing planned: Yes. The de-identified data will be shared upon request to PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiyeon Kang principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bodyweight augment system and Smart insole in people with Cerebral Palsy, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 10m walk between pre/post evaluation and 6 Training sessions (time frame: through study completion, an average of 5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.